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

NCT06172114 | Not Yet Recruiting

• 1 other identifier: MBRU-PRF
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dental Implants; Tooth Extraction; Bone Regeneration

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years

Secondary Outcomes (5)

• 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

• 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

• 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

Study Arms (2)

Control group (C)

ACTIVE COMPARATOR

Xenograft + resorbable collagen membrane

Procedure: Alveolar ridge preservation using sticky bone

Test group (T)

EXPERIMENTAL

Xenograft combined with L-PRF + resorbable collagen membrane

Procedure: Alveolar ridge preservation using sticky bone

Interventions

Alveolar ridge preservation using sticky bone PROCEDURE

In the test group the xenograft will be mixed in with the L-PRF then placed into the socket.

Control group (C); Test group (T)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 15, 2023
• Study Start: April 20, 2024
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share