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Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone

Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone. A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07649239
Enrollment
26
Registered
2026-06-16
Start date
2026-01-10
Completion date
2027-02-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Connective Tissue Graft, Peri-Implant Health, PRF, Soft Tissue, Soft Tissue Augmentation at Dental Implants

Brief summary

An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants. The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant. While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.

Detailed description

An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.13, 14 Recent studies have shown that the multilayering of the PRF membrane around implants have the same effect on peri-implant mucosal thickness in comparison to the gold standard which is the connective tissue graft without further patient morbidity 13, 14. PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants. The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant. While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.7, 8 Additionally, the stabilized PRF membrane ensures prolonged exposure of the wound site to bioactive growth factors. Given these advantages, the potential benefits of using PRF membrane with dental implants in the anterior region need further exploration. Thus, this study focuses on comparing multilayering PRF membrane with the gold standard which is the CTG in healing period of 2nd stage implant surgery.

Interventions

PROCEDUREPlatelet rich fibrin multilayered Platelet-rich fibrin (PRF) A t the second stage

The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.

PROCEDURESoft tissue augmentation around dental implants with CTG in the second stage

The test group will be treated with dental implant and CTG. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.

Sponsors

Gulf Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

-Inclusion Criteria: Patients with single bounded missing tooth in the esthetic zone Patients in the age group of 21-65 years Patients having good oral hygiene (mean plaque score of \< 25%) and with stable periodontal status. -

Exclusion criteria

Smokers patients Patients with poor maintenance of oral hygiene, as determined by a mean plaque score of ≥ 25% despite efforts by the clinician to improve oral hygiene maintenance. Patients with medically compromised conditions like uncontrolled diabetes mellitus or any systemic diseases that may result in compromised hard and soft tissue healing.

Design outcomes

Primary

MeasureTime frameDescription
Peri-implant soft tissue thicknessTime Frame: 6 weeks and 3 and 6 monthsVolumetric

Secondary

MeasureTime frameDescription
width of the keratinized tissue around dental implantsTime Frame: baseline, 3 and 6 monthsPeriodontal probe mm
Marginal bone loss6 monthsCBCT measurement
Postoperative patient satisfaction VAS 0-5baseline, 2 weeks, 6 monthsVAS 0-5

Countries

United Arab Emirates

Contacts

CONTACTNesma Shemais, PhD
dr.nesma@gmu.ac.ae0529961988
STUDY_DIRECTORNesma MF Shemais

Assistant professor of Periodontology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026