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.
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.
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).
Parallel
Connective Tissue Graft (CTG)
Procedure/SurgeryPeri-implant soft tissue augmentation performed using a subepithelial connective tissue graft harvested from the palate during implant second-stage surgery. The graft is placed at the buccal aspect of the implant site to increase mucosal thickness and improve peri-implant soft tissue phenotype.
Microneedling with Injectable Platelet-Rich Fibrin (MN+i-PRF)
Procedure/SurgeryPeri-implant soft tissue augmentation performed using automated microneedling followed by injection of autologous injectable platelet-rich fibrin (i-PRF) during implant second-stage surgery. The intervention is repeated at 2 and 4 weeks postoperatively to enhance peri-implant soft tissue thickness and quality.
Mucosal Thickness
Change in buccal peri-implant mucosal thickness (mm) measured at the mid-facial aspect, 2 mm apical to the mucosal margin, using standardized transgingival probing through a custom stent. Measurements will be compared between baseline and follow-up examinations.
Keratinized Tissue Width (KTW)
Change in keratinized tissue width (mm) measured at the mid-facial aspect from the mucosal margin to the mucogingival junction using a calibrated periodontal probe.
Peri-implant Probing Depth (PD)
Peri-implant probing depth (mm) measured at four sites per implant (mesiobuccal, mid-buccal, distobuccal, and lingual/palatal) using a calibrated periodontal probe and standardized probing force.
Bleeding on Probing (BOP)
Presence or absence of bleeding following gentle periodontal probing at four peri-implant sites. Bleeding on probing will be recorded as an indicator of peri-implant soft tissue health.
Volumetric Soft Tissue Contour Change
Volumetric changes in peri-implant soft tissues assessed using intraoral digital scans and three-dimensional superimposition of STL files obtained at baseline and follow-up visits.
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