Bovine-derived Xenograft (Bio-Oss Collagen) With or Without Leukocyte-platelet Rich Fibrin (L-PRF) for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial

Mohammed Bin Rashid University of Medicine and Health Sciences0 sites34 target enrollmentApril 20, 2024

ConditionsDental Implants Tooth Extraction Bone Regeneration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Implants
Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences
Enrollment: 34
Primary Endpoint: Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes

Registry

clinicaltrials.gov

Start Date

April 20, 2024

End Date

December 9, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Mohammed Bin Rashid University of Medicine and Health Sciences

Responsible Party

Principal Investigator

Abeer Hakam

Assistant professor

Mohammed Bin Rashid University of Medicine and Health Sciences

Eligibility Criteria

Inclusion Criteria

•Aged 18 or over.
•Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
•The tooth that requires extraction is bordered by two teeth.
•Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
•Good compliance and commitment to attend follow-up review appointments.
•Willing to provide informed consent.

Exclusion Criteria

•Localised / generalised periodontitis.
•Presence of acute periapical lesion.
•Bone metabolic disease and/or taking medications that affect bone metabolism.
•Long term use of non-steroidal anti-inflammatory medications.
•History of malignancy, radiotherapy or chemotherapy.
•Pregnant or lactating women.
•Severe bruxism or parafunctional habits.
•Large occlusal discrepancies.

Outcomes

Primary Outcomes

Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.

Time Frame: 2 years

Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation.

Time Frame: 2 years

Reporting a score will be done using the pain visual analogue scale. Minimum value is 0 which is no pain and maximum value is 10 which is the worst pain ever experienced.

Secondary Outcomes

Need for additional bone augmentation will only be assessed at the time of implant placement by recording the use of bone graft (if required) in the clinical notes.(2 years)
Changes in peri-implant marginal bone level will be assessed at implant placement (baseline) and after one year of implant restoration and annually up to two years using standardized peri-apical radiograph.(2 years)
Soft tissue levels (midbuccal marginal tissue level changes, interproximal papilla level changes and changes in width of keratinised tissue) will be assessed at implant placement (baseline), at 1 year and at 2 years(2 years)
Changes in width and height of alveolar ridge will be assessed at the time of tooth extraction and ridge preservation, six months (prior to implant placement) and annually up to two years using cone beam computed tomography (CBCT).(2 years)
Biological complications (i.e. peri-implant diseases) will be assessed clinically using periodontal probe after one year of implant restoration and annually up to two years.(2 years)