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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172114
• Other study ID #: MBRU-PRF
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: December 9, 2025

Study information

• Verified date: March 2024
• Source: Mohammed Bin Rashid University of Medicine and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: December 9, 2025
• Est. primary completion date: December 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Regeneration
• Dental Implants
• Tooth Extraction

Intervention

Procedure:
• Alveolar ridge preservation using sticky bone
In the test group the xenograft will be mixed in with the L-PRF then placed into the socket.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed Bin Rashid University of Medicine and Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.		2 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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