Clinical trial NCT06172114: Bovine-derived Xenograft With or Without L-PRF for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implants
Tooth Extraction
Bone Regeneration
Lead sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years.
timeFrame: 2 years
measure: Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation.
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
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