Hyaluronic Acid Versus I-PRF Combined With Microneedling for Peri Implant Soft Tissue Enhancement: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 42
- Primary Endpoint
- Peri-implant gingival thickness
Study Overview
Brief Summary
This study aims to compare the use of microneedling alone versus with hyaluronic acid or i-PRF in conjunction with microneedling in peri-implant mucosa in the esthetic zone to test the superior increase in gingival thickness.
Detailed Description
Despite the rising demand for esthetics and the prevailing use of dental implants in the recent era, the soft tissue remains a dilemma that affects patients' satisfaction and the implants' longevity in the oral environment, especially in the esthetic region of the maxilla. Various studies have been done to test the effectiveness of microneedling, hyaluronic acid, and i-PRF as alternative non-invasive or minimally invasive methods targeting tissue enhancement in the gingiva, and have proven that they have notable and desirable results. However, there is a lack in the literature regarding the use of these previously mentioned treatment options with regard to peri-implant soft tissue, and which of the delivered solutions offers superior results with reference to peri-implant mucosa in conjunction with microneedling.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with delayed implants placed in the maxillary esthetic region in correct positioning and angulation
- •Patients with peri-implant gingival thickness ≤ 1 mm
- •Patients with healthy gingiva and who can maintain good oral hygiene around implants
Exclusion Criteria
- •Marginal bone loss ≤ 2 mm
- •Patients with peri-implantitis or periodontitis
- •Patients with systemic conditions or diseases impairing healing or soft tissue metabolism
- •Pregnant or lactating females
- •Patients taking medications affecting the gingiva
Arms & Interventions
Microneedling
microneedling into the peri-implant soft tissue site
Microneedling with Hyaluronic Acid (HA)
Microneedling into the peri-implant soft tissue site in addition to the use of HA, repeated 3 times with 7 days gap in between.
Intervention: Hyaluronic Acid (HA) (Drug)
Microneedling with injectable platelet rich fibrin (I-PRF)
Microneedling into the peri-implant soft tissue site, in addition to the use of I-PRF, repeated 3 times with 7 days gap in between.
Intervention: Platelet rich fibrin (Biological)
Outcomes
Primary Outcomes
Peri-implant gingival thickness
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Rahaf Medhat Zayn
Principal investigator
Ain Shams University