Bovine-derived Xenograft With or Without L-PRF for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Tooth Extraction; Dental Implants; Bone Regeneration
• Interventions: Procedure: Alveolar ridge preservation using sticky bone

• Registration Number: NCT06172114
• Lead Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Study Start: 2024-04-20
• Primary Completion: 2025-12-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control group (C)	Alveolar ridge preservation using sticky bone	Xenograft + resorbable collagen membrane
Test group (T)	Alveolar ridge preservation using sticky bone	Xenograft combined with L-PRF + resorbable collagen membrane

Primary Outcome Measures

Name	Time	Method
Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.	2 years
Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation.	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 Outcome Measures

Name	Time	Method
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