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

Mohammed Bin Rashid University of Medicine and Health Sciences34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Implants Tooth Extraction Bone Regeneration

Interventions

Alveolar ridge preservation using sticky bonePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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.

Time frame: 2 years

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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