Dataset Information

Histological, radiological, and clinical outcomes of sinus floor elevation using a lateral approach for pre-/post-extraction of the severely compromised maxillary molars: a study protocol for a randomized controlled trial.

ABSTRACT:

Background

The volume of residual alveolar bone is critical to the survival of dental implants. When the volume of alveolar bone in the posterior maxillary region is less than 4?mm, maxillary sinus floor elevation (MSFE) with the lateral approach is an effective option. Traditionally, this standard approach is usually conducted at 4-6?months after tooth extraction (standard MSFE). However, defective dentition due to extraction can impair mastication during the period of bone remodeling, especially if the molars on both sides are severely compromised and must be extracted. MSFE before extraction (modified MSFE) can take full advantage of residual tooth strength. However, the effectiveness and practicability of the modified MSFE procedure remain unknown. Therefore, the aim of this study was to compare the clinical outcomes of modified vs. standard MSFE, in order to provide references to periodontists.

Methods/design

The study cohort included 25 adult patients (50 surgery sites) recruited from Peking University Hospital and School of Stomatology who met the inclusion criteria. The two sides of each patient will be randomly divided into two groups: a test group-modified MSFE or a control group-standard MSFE. The surgical duration and patient-reported outcomes (visual analog scale for discomfort) will be documented. Clinical indicators, including implant survival rates, mucosal conditions, and complications, will be recorded every 6?months during the 5-year follow-up period. The volume of the alveolar bone and marginal bone level will be assessed radiographically (cone-beam CT and periapical films) every 6?months. Histological analysis of biopsy samples retrieved from both sides will be performed to evaluate the biological features of the bone.

Discussion

The current study will explore the implant survival rates, safety, reliability, effectiveness, and practicability of the modified MSFE procedure. Moreover, the extent of osteogenesis on the sinus floor will also be assessed. The results of this trial will provide strategies for the modified MSFE procedure to achieve ideal clinical outcomes.

Trial registration

International Clinical Trials Registry Platform ChiCTR1900020648 . Registered on 1 January 2019.

SUBMITTER: Yue Z

PROVIDER: S-EPMC7844904 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Histological, radiological, and clinical outcomes of sinus floor elevation using a lateral approach for pre-/post-extraction of the severely compromised maxillary molars: a study protocol for a randomized controlled trial.

Yue Zhaoguo Z Liu Qi Q Zhang Haidong H Yang Jingwen J Hou Jianxia J

Trials 20210128 1

<h4>Background</h4>The volume of residual alveolar bone is critical to the survival of dental implants. When the volume of alveolar bone in the posterior maxillary region is less than 4 mm, maxillary sinus floor elevation (MSFE) with the lateral approach is an effective option. Traditionally, this standard approach is usually conducted at 4-6 months after tooth extraction (standard MSFE). However, defective dentition due to extraction can impair mastication during the period of bone remodeling, ...[more]

PMID: 33509257

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Project description:This study evaluates the clinical, radiological, histological, and histomorphometric aspects of a fully synthetic biphasic calcium phosphate (BCP) (60% hydroxyapatite and 40% ß-tricalcium phosphate), used in a human maxillary sinus floor elevation (MSFE) procedure with 9- and 12-month healing time.A unilateral MSFE procedure, using 100% BCP, was performed in two series of five patients with healing times of 9 and 12 months respectively. Clinical and radiological parameters were measured up to 5 years postoperatively. Biopsy retrieval was carried out during dental implants placement. Histology and histomorphometry were performed on 5-μm sections of undecalcified bone biopsies.The MSFE procedure with BCP showed uneventful healing in all cases. All dental implants appeared to be well osseointegrated after 3 months. Radiological evaluation showed less than 1 mm tissue height loss from MSFE to the 5-year follow-up examination. No signs of inflammation were detected on histological examination. Newly formed mineralized tissue was found cranially from the native bone. The BCP particles were surrounded by connective tissue, osteoid islands, and newly formed bone. Mineralized bone tissue was in intimate contact with the BCP particles. After 12 months, remnants of BCP were still present. The newly formed bone had a trabecular structure. Bone maturation was demonstrated by the presence of lamellar bone. Histomorphometric analysis showed at 9 and 12 months respectively an average vital bone volume/total volume of 35.2 and 28.2%, bone surface/total volume of 4.2 mm2/mm3 and 8.3 mm2/mm3, trabecular thickness of 224.7 and 66.7 μm, osteoid volume/bone volume of 8.8 and 3.4%, osteoid surface/bone surface (OS/BS) of 42.4 and 8.2%, and osteoid thickness of 93.9 and 13.6 μm.MFSE with BCP resulted in new bone formation within the augmented sinus floor and allowed the osseointegration of dental implants in both groups. From a histological and histomorphometric perspective, a 9-month healing time for this type of BCP may be the optimal time for placement of dental implants.

Project description:BACKGROUND:Implant placement in the posterior maxilla is often complicated by the insufficient bone volume. While transalveolar sinus floor elevation (TSFE) has been proven as a predictable surgical procedure to increase the bone height in the posterior maxilla, questions in regard to the necessity of the bone grafting during the sinus lift and the question of whether TSFE could be performed when the residual bone height is below 5 mm are still debated. Furthermore, high-quality evidence comparing the clinical outcome of transalveolar sinus floor elevation with osteotome and modified sinus floor elevation with crestal non-cutting drills is limited. METHODS/DESIGN:One hundred twenty adult patients who fit the inclusion criteria are being recruited from the Peking University Hospital of Stomatology First Clinical Division (Beijing, China). All patients are assigned to one of four groups according to a table of random numbers. Participants will receive (1) TSFE using osteotomes with bone grafting, (2) TSFE using osteotomes without bone grafting, (3) modified TSFE with bone grafting, or (4) modified TSFE without bone grafting. In a one-year follow-up period, implant survival rates, complications, implant stability, bone remodeling around the implant, and patient-reported outcome (visual analog scale for intraoperative discomfort and postoperative pain) will be observed and documented. The implant stability will be gauged by the resonance frequency analysis six times (at baseline and weeks 6, 8, 12, 16, and 26), and the bone remodeling will be observed and compared via radiographic examinations. DISCUSSION:The result of the trial will potentially contribute to better decision making in atrophic posterior maxilla when implant placement is needed. Therefore, if the outcome is deemed favorable, the use of the modified TSFE would achieve an outcome equivalent to that of the traditional TSFE while introducing less trauma and postoperative discomforts. Separately, whether the bone graft procedure is necessary for the TSFE will also be discussed. TRIAL REGISTRATION:The study has been registered in ClinicalTrials.gov under the identifier number NCT03445039 . Registered on 26 February 2018.

Dataset Information

Histological, radiological, and clinical outcomes of sinus floor elevation using a lateral approach for pre-/post-extraction of the severely compromised maxillary molars: a study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Histological, radiological, and clinical outcomes of sinus floor elevation using a lateral approach for pre-/post-extraction of the severely compromised maxillary molars: a study protocol for a randomized controlled trial.

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