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Recruiting NCT07649239

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

No phase Interventional Soft Tissue Peri-Implant Health Soft Tissue Augmentation at Dental Implants Connective Tissue Graft

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) A t the second stage, Soft tissue augmentation around dental implants with CTG in the second stage.
Who it may be relevant to
Registry conditions: Soft Tissue, Peri-Implant Health, Soft Tissue Augmentation at Dental Implants, Connective Tissue Graft. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Platelet 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 le
  • Procedure Soft 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 grou

Primary outcome measures

  • Peri-implant soft tissue thickness [Time frame: Time Frame: 6 weeks and 3 and 6 months]
Secondary outcome measures (3)
  • width of the keratinized tissue around dental implants [Time frame: Time Frame: baseline, 3 and 6 months]
  • Marginal bone loss [Time frame: 6 months]
  • Postoperative patient satisfaction VAS 0-5 [Time frame: baseline, 2 weeks, 6 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Arab Emirates · 1 center
  • Gulf Medical University — Ajman

Identifiers

NCT: NCT07649239 · ZainabMDSperio

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗