Healing of intrabony defects following regenerative surgery by means of single-flap approach in conjunction with either hyaluronic acid or an enamel matrix derivative: a 24-month randomized controlled clinical trial.
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ABSTRACT: Objectives
The aim of this randomized controlled clinical trial was to compare the clinical outcomes obtained in intrabony defects following regenerative periodontal surgery using the single-flap approach (SFA) in conjunction with either hyaluronic acid (HA) or enamel matrix derivative (EMD).Materials and methods
Thirty-two intrabony defects in 32 healthy subjects were randomly assigned: HA (test group) or EMD (control group). Clinical attachment level (CAL), probing depth (PD), gingival recession (REC), and bleeding on probing (BOP) were recorded at baseline,12, 18, and 24 months after surgery.Results
At 24 months, both treatments resulted in statistically significant clinical improvements evidenced by PD-reduction and CAL-gain (p<0.001). The mean CAL-gain was 2.19±1.11 mm in the test and 2.94±1.12 mm in the control sites (p=0.067). PD-reduction was statistically significantly higher for the control group (4.5±0.97 mm) than the test group (3.31±0.70 mm), (p=0.001). CAL-gain ≤ 3 mm was observed in 87.5% and in 62.5% of the test and control sites, respectively. Test sites showed slightly lower REC values than the control sites. No statistically significant differences were found for BOP between treatments.Conclusions
The present findings indicate that both treatments led to statistically significant clinical improvements compared to baseline, although the application of EMD resulted in statistically significantly higher PD-reduction compared to the use of HA.Clinical relevance
The use of HA in conjunction with a SFA resulted in significant PD-reduction and CAL-gain, pointing to the potential clinical relevance of this material in regenerative periodontal surgery.
SUBMITTER: Pilloni A
PROVIDER: S-EPMC8342388 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo date, enamel matrix derivative (EMD) has been considered to be one of the few biomaterials for clinical use capable of demonstrating true periodontal regeneration. The aim of this two-center prospective clinical study was to evaluate 2-year outcome of periodontal regenerative therapy using EMD in the treatment of intrabony defects, performed as an 'advanced medical treatment' under the national healthcare system in Japan.ResultsPatients with chronic periodontitis who have completed initial periodontal therapy at either of the two dental school clinics were enrolled. Each contributed at least one intrabony defect of ≥3 mm in depth. During surgery, EMD was applied to the defect following debridement. Twenty-two participants (mean age 55.2 years old, 9 men and 13 women) completed 2-year reevaluation, and a total of 42 defects were subjected to data analysis. Mean gains in clinical attachment level (CAL) at 1 and 2 years were 2.9 mm (38% of baseline CAL) and 3.1 mm (41%), respectively, both showing a significant improvement from baseline. There was also a significant reduction in probing depth (PD): mean reductions at 1 and 2 years were 3.2 and 3.3 mm, respectively. There was a progressive improvement in the mean percentages of bone fill from 26% at 1 year to 36% at 2 years. No significant difference in CAL gain at 2 years was found between 3-wall bone defects and other defect types combined. In multiple regression analysis, the baseline PD was significantly associated with CAL gain at 2 years. In this population of patients, the treatment of intrabony defects with EMD yielded clinically favorable outcomes, as assessed by periodontal and radiographical parameters, over a period of 2 years.
| S-EPMC5501118 | biostudies-literature
Project description:ObjectivesMinimally invasive flap designs have been introduced to enhance blood clot stability and support wound healing. Limited data appear to suggest, that in intrabony defects, better clinical outcomes can be achieved by means of minimally invasive flap compared to more extended flaps. The aim of this study was to evaluate the healing of intrabony defects treated with either minimally invasive surgical flaps or with modified or simplified papilla preservation techniques in conjunction with the application of an enamel matrix derivative (EMD).Materials and methodsForty-seven subjects were randomly assigned to either test (N = 23) or control (N = 24) procedures. In the test group, the intrabony defects were accessed by means of either minimally invasive surgical technique (MIST) or modified minimally invasive surgical technique (M-MIST) according to the defect localization while the defects in the control group were treated with either the modified or simplified papilla preservation (MPP) or the simplified papilla preservation technique (SPP). EMD was used as regenerative material in all defects. The following clinical parameters were recorded at baseline and after 12 months: full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depths (PD), clinical attachment level (CAL), and gingival recession (GR). Early healing index (EHI) score was assessed in both groups 1 week following the surgery. CAL gain was set as primary outcome.ResultsAfter 12 months follow-up, the CAL gain was 4.09 ± 1.68 mm in test group and 3.79 ± 1.67 mm in control group, while the PD reduction was 4.52 ± 1.34 mm and 4.04 ± 1.62 mm for test and control sites. In both groups, a minimal GR increase (0.35 ± 1.11 mm and 0.25 ± 1.03 mm) was noted. No residual PDs ≥ 6 mm were recorded in both groups. CAL gains of 4-5 mm were achieved in 30.4% and in 29.2% of test and control group, respectively. Moreover, CAL gains ≥ 6 mm were recorded in 21.7% of experimental sites and in 20.8% of control sites. No statistically significant differences in any of the evaluated parameters were found between the test and control procedures (P > 0.05). After 1 week post-surgery, a statistically significant difference (P < 0.05) between the groups was found in terms of EHI score.ConclusionsWithin the limits of this pilot RCT, the results have failed to show any differences in the measured parameters following treatment of intrabony defects with EMD, irrespective of the employed surgical technique.Clinical relevanceIn intrabony defects, the application of EMD in conjunction with either MIST/M-MIST or M-PPT/SPPT resulted in substantial clinical improvements.
| S-EPMC8816368 | biostudies-literature
Project description:The present study aimed to investigate the periodontal regenerative effect of enamel matrix derivative (EMD) in diabetes. Thirty-six rats were assigned to streptozotocin-induced diabetes or control (non-diabetic) groups. Three-wall intrabony defects were surgically generated in the bilateral maxilla molar, followed by application of EMD or saline. Primary wound closure and defect fill were evaluated via histomorphological analysis and micro-computed tomography. mRNA expression levels of inflammatory and angiogenic factors in the defects were quantified via real-time polymerase chain reaction. Gingival fibroblasts were isolated from control animals and cultured in high-glucose (HG) or control medium. The effects of EMD on insulin resistance and PI3K/Akt/VEGF signaling were evaluated. The achievement rate of primary closure and the parameters of defect fill were significantly higher at EMD-treated site than at EMD-untreated sites in both diabetic and non-diabetic rats, although defect fill in the diabetic groups was significantly lower in the control groups on two-way repeated-measures analysis of variance (for both, p<0.05). Newly formed bone and cementum were significantly increased at EMD-treated sites in diabetic rats than at EMD-untreated sites in control rats (for both, p<0.05). Vegf was significantly upregulated at EMD-treated sites in both diabetic and non-diabetic rats (for both, p<0.05). In vitro, insulin or EMD-induced Akt phosphorylation was significantly lower in cells cultured in HG medium (p<0.05). EMD-mediated Vegf upregulation was suppressed by the Akt inhibitor wortmannin, although the effect was significantly lower in HG medium (p<0.01). In conclusion, EMD might promote periodontal tissue regeneration via Akt/VEGF signaling, even in a diabetic condition.
| S-EPMC6237339 | biostudies-literature
Project description:The combination of enamel matrix derivative (EMD) with an autogenous bone graft in periodontal regeneration has been proposed to improve clinical outcomes, especially in case of deep non-contained periodontal defects, with variable results. The aim of the present systematic review and meta-analysis was to assess the efficacy of EMD in combination with autogenous bone graft compared with the use of EMD alone for the regeneration of periodontal intrabony defects. A literature search in PubMed and in the Cochrane Central Register of Controlled Trials was carried out on February 2019 using an ad-hoc search string created by two independent and calibrated reviewers. All randomized controlled trials (RCTs) comparing a combination of EMD and autogenous bone graft with EMD alone for the treatment of periodontal intrabony defects were included. Studies involving other graft materials were excluded. The requested follow-up was at least 6 months. There was no restriction on age or number of patients. Standard difference in means between test and control groups as well as relative forest plots were calculated for clinical attachment level gain (CALgain), probing depth reduction (PDred), and gingival recession increase (RECinc). Three RCTs reporting on 79 patients and 98 intrabony defects were selected for the analysis. Statistical heterogeneity was detected as significantly high in the analysis of PDred and RECinc (I2 = 85.28%, p = 0.001; I2 = 73.95%, p = 0.022, respectively), but not in the analysis of CALgain (I2 = 59.30%, p = 0.086). Standard difference in means (SDM) for CALgain between test and control groups amounted to -0.34 mm (95% CI -0.77 to 0.09; p = 0.12). SDM for PDred amounted to -0.43 mm (95% CI -0.86 to 0.01; p = 0.06). SDM for RECinc amounted to 0.12 mm (95% CI -0.30 to 0.55. p = 0.57). Within their limits, the obtained results indicate that the combination of enamel matrix derivative and autogenous bone graft may result in non-significant additional clinical improvements in terms of CALgain, PDred, and RECinc compared with those obtained with EMD alone. Several factors, including the surgical protocol used (e.g. supracrestal soft tissue preservation techniques) could have masked the potential additional benefit of the combined approach. Further well-designed randomized controlled trials, with well-defined selection criteria and operative protocols, are needed to draw more definite conclusions.
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Project description:BackgroundIn the regenerative treatment of intrabony periodontal defects, surgical strategies are primarily determined by defect morphologies. In certain cases, however, direct clinical measurements and intraoral radiographs do not provide sufficient information on defect morphologies. Therefore, the application of cone-beam computed tomography (CBCT) has been proposed in specific cases. 3D virtual models reconstructed with automatic thresholding algorithms have already been used for diagnostic purposes. The aim of this study was to utilize 3D virtual models, generated with a semi-automatic segmentation method, for the treatment planning of minimally invasive periodontal surgeries and to evaluate the accuracy of the virtual models, by comparing digital measurements to direct intrasurgical measurements.MethodsFour patients with a total of six intrabony periodontal defects were enrolled in the present study. Two months following initial periodontal treatment, a CBCT scan was taken. The novel semi-automatic segmentation method was performed in an open-source medical image processing software (3D Slicer) to acquire virtual 3D models of alveolar and dental structures. Intrasurgical and digital measurements were taken, and results were compared to validate the accuracy of the digital models. Defect characteristics were determined prior to surgery with conventional diagnostic methods and 3D virtual models. Diagnostic assessments were compared to the actual defect morphology during surgery.ResultsDifferences between intrasurgical and digital measurements in depth and width of intrabony components of periodontal defects averaged 0.31 ± 0.21 mm and 0.41 ± 0.44 mm, respectively. In five out of six cases, defect characteristics could not be assessed precisely with direct clinical measurements and intraoral radiographs. 3D models generated with the presented semi-automatic segmentation method depicted the defect characteristics correctly in all six cases.ConclusionIt can be concluded that 3D virtual models acquired with the described semi-automatic segmentation method provide accurate information on intrabony periodontal defect morphologies, thus influencing the treatment strategy. Within the limitations of this study, models were found to be accurate; however, further investigation with a standardized validation process on a large number of participants has to be conducted.
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Project description:Background: Pyroptosis is a caspase-dependent catabolic process relevant to periodontal disorders for which inflammation is central to the pathophysiology of the disease. Although enamel matrix derivative (EMD) has been applied to support periodontal regeneration, its capacity to modulate the expression of pyroptosis-related genes remains unknown. Considering EMD has anti-inflammatory properties and pyroptosis is linked to the activation of the inflammasome in chronic periodontitis, the question arises whether EMD could reduce pyroptosis signalling. Methods: To answer this question, primary macrophages obtained from murine bone marrow and RAW 264.7 macrophages were primed with EMD before being challenged by lipopolysaccharide (LPS). Cells were then analysed for pyroptosis-signalling components by gene expression analyses, interleukin-1β (IL-1β) immunoassay, and the detection of caspase-1 (CAS1). The release of mitochondrial reactive oxygen species (ROS) was also detected. Results: We report here that EMD, like the inflammasome (NLRP3) and CAS1 specific inhibitors-MCC950 and Ac-YVAD-cmk, respectively-lowered the LPS-induced expression of NLRP3 in primary macrophages (EMD: p = 0.0232; MCC950: p = 0.0426; Ac-YVAD-cmk: p = 0.0317). EMD further reduced the LPS-induced expression of NLRP3 in RAW 264.7 cells (p = 0.0043). There was also a reduction in CAS1 and IL-1β in RAW 264.7 macrophages on the transcriptional level (p = 0.0598; p = 0.0283; respectively), in IL-1β protein release (p = 0.0313), and CAS1 activity. Consistently, EMD, like MCC950 and Ac-YVAD-cmk, diminished the ROS release in activated RAW 264.7 cells. In ST2 murine mesenchymal cells, EMD could not be tested because LPS, saliva, and IL-1β + TNF-α failed to provoke pyroptosis signalling. Conclusion: These findings suggest that EMD is capable of dampening the expression of pyroptosis-related genes in macrophages.
| S-EPMC9099857 | biostudies-literature
Project description:Objectives"Form and function restoration" is the ultimate goal of reconstructive surgery, which is oriented toward regeneration rather than reparation. Recently, research in reconstructive surgery has focused on the regenerative potential of the adipose tissue. The aim of the study is to illustrate the surgical methods and show the functional and aesthetic results achieved by the reconstruction of finger soft-tissue defects using homodigital dorsal adipofascial reverse flap (HDARF).Materials and methodsA total of 63 cases (45 acute and 18 elective) were included between September 2010 and August 2016. In each case, we preliminarily performed surgical debridement and then harvested an adipofascial flap from the back of the finger. Nine injured thumbs that were repaired with the flap as emergency cases were also included. The average age of the patients was 46 (range: 4-69) years.ResultsAll flaps survived without any complications during the 24-month follow-up. Good nail regrowth through the flap and full regeneration were observed in approximately all cases. Sensitivity tests and histological analysis of biopsy samples of the regenerated fingers confirmed full regeneration of the epidermis, dermis, cutaneous adnexa, and nerves. All the patients were satisfied with the hand functionality and aesthetic appearance.ConclusionThe HDARF represents a very useful alternative for the reconstruction of nailbed crushes, achieving regeneration of injured segments in deformities caused by trauma or infection.
| S-EPMC7061596 | biostudies-literature
Project description:BackgroundHyaluronic acid (HA) fillers are an established intervention for correcting facial volume deficiency. Few studies have evaluated treatment outcomes for longer than 6 months. The purpose of this study was to determine the durability of an HA filler in the correction of midface volume deficiency over 24 months, as independently evaluated by physician investigators and subjects.MethodsSubjects received treatment with Juvéderm(™) Voluma(™) to the malar area, based on the investigators' determination of baseline severity and aesthetic goals. The treatment was administered in one or two sessions over an initial 4-week period. Supplementary treatment was permissible at week 78, based on protocol-defined criteria. A clinically meaningful response was predefined as at least a one-point improvement on the MidFace Volume Deficit Scale (MFVDS) and on the Global Aesthetic Improvement Scale (GAIS).ResultsOf the 103 subjects enrolled, 84% had moderate or significant volume deficiency at baseline. At the first post-treatment evaluation (week 8), 96% were documented to be MFVDS responders, with 98% and 100% graded as GAIS responders when assessed by the subjects and investigators, respectively. At week 78, 81.7% of subjects were still MFVDS responders, with 73.2% and 78.1% being GAIS responders, respectively. Seventy-two subjects completed the 24-month study, of whom 45 did not receive supplementary Voluma(™) at week 78. Forty-three of the 45 (95.6%) subjects were MFVDS responders, with 82.2% and 91.1% being GAIS responders, respectively. At end of the study, 66/72 subjects were either satisfied or very satisfied with Voluma(™), with 70/72 indicating that they would recommend the product to others. Adverse events were transient and infrequent, with injection site bruising and swelling being the most commonly reported.ConclusionVoluma(™) is safe and effective in the correction of mild to severe facial volume deficiency, achieving long-term clinically meaningful results. There was a high degree of satisfaction with the treatment outcome over the 24 months of the study.
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Project description:In stage IV periodontitis patients with pathologic tooth migration (PTM), interdisciplinary treatment includes regenerative periodontal surgery (RPS) with an application of biomaterials and orthodontic therapy (OT) to restore function, esthetics and thereby quality of life (QoL). In a 24-month randomized trial we explored the synergy between regenerative medicine and biomechanical force application. The following methods were used: Forty-three patients had been randomized to a combined treatment comprising RPS and subsequent OT starting either 4 weeks (early OT) or 6 months (late OT) post-operatively. Clinical periodontal parameters and oral health-related QoL (GOHAI) were recorded up to 24 months. We obtained the following results: Mean clinical attachment gain (∆CAL ± SD) was significantly higher with early OT (5.96 ± 2.1 mm) versus late OT (4.65 ± 1.76 mm) (p = 0.034). Pocket closure (PPD ≤ 4 mm) was obtained in 91% of defects with early OT compared to 90% with late OT. GOHAI-scores decreased significantly from 26.1 ± 7.5 to 9.6 ± 4.7 (early OT) and 25.1 ± 7.1 to 12.7 ± 5.6 (late OT). Inconclusion, teeth severely compromised by intrabony defects and PTM can be treated successfully by RPS followed by early OT with the advantage of an overall reduced treatment time. As a result of the combined periodontal-orthodontic therapy, the oral health-related QoL of patients was significantly improved. Early stimulation of wound healing with orthodontic forces had a favorable impact on the outcomes of regenerative periodontal surgery.
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Project description:ObjectivesThis is a double-blind, split-mouth, randomized clinical study that aims to evaluate the influence of bulk-fill composite packaging presented in syringes (BSy) and capsules (BCa), and the effect of selective enamel etching (SEE) on the clinical performance of class I and II bulk-fill resin composite restorations after 24 months.MethodologyA total of 295 class I or class II restorations were performed on 70 patients. One universal adhesive was applied in all restorations. SEE was used in 148 restorations and self-etching mode (SET) in 147 restorations. After the adhesive application, cavities were restored with Filtek Bulk-fill Posterior Restorative in syringes (BSy), Filtek One Bulk-fill in capsules (BCa), or Filtek Supreme Ultra in syringes with the incremental technique (In). All restorations were evaluated using the FDI criteria after one week and after six, 12, and 24 months. Kaplan-Meier survival analysis and Pearson's Chi-square test were used (α=0.05) for statistical analysis.ResultsAfter 24 months, 62 patients were evaluated and four restorations were lost due to fracture (one for SEEBSy, two for SEEIn, and one for SETIn). No significant differences in the fracture and retention rate were found between groups (p>0.05). SEE showed significantly fewer marginal adaptation defects than SET (p<0.05). BCa and BSy groups showed fewer marginal discrepancies compared to In (p<0.05). Restorations performed with BCa showed less color mismatch than BSy or In (p<0.05).ConclusionAlthough all restorations exhibited satisfactory clinical performance after 24 months of clinical service, the clinical behavior of class I and II restorations' improved when performed with a bulk-fill composite in capsules, mainly when associated with a universal adhesive applied with SEE.
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