Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeirut Arab University

About this trial

This randomized controlled clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Patients with thin peri-implant soft tissue requiring implant second-stage surgery in the esthetic zone will be randomly assigned to receive either CTG harvested from the palate or a series of microneedling and i-PRF treatments. Clinical outcomes including mucosal thickness, keratinized tissue width, peri-implant health parameters, volumetric soft tissue changes, esthetic outcomes, and patient-reported measures of pain and satisfaction will be evaluated during follow-up. The study aims to determine whether microneedling with i-PRF can provide comparable soft tissue augmentation while reducing patient morbidity associated with connective tissue graft harvesting.

Eligibility criteria

Qualifiers

Systemically healthy adults (Between 18 and 65) with one or more dental implants requiring second-stage surgery in the esthetic zone (Anteriors and Premolars).

Thin soft tissue phenotype: mucosal thickness or KTW <2 mm buccally.

Stable osseointegrated implant, adequate restorative space, and healthy adjacent teeth.

Good oral hygiene (PI ≤10%), with peri-implant maintenance.

Disqualifiers

Heavy smokers (≥10 cig/day); light smokers only if reduced.

Systemic/healing issues: uncontrolled diabetes, immunocompromise, bleeding disorders, anticoagulants, steroids.

Pregnancy or breastfeeding.

Active infection (periodontal or peri-implant).

Trial design

Treatments tested in this trial

  • Connective Tissue Graft (CTG)
  • Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators