Clinical and Volumetric Changes Following Single Pontic Site Development Using Multilayered Platelet Rich Fibrin Versus Connective Tissue Grafting in the Maxillary Esthetic Zone

NCT06926452 | Not Yet Recruiting DMC

• 1 other identifier: PRF vs CTG
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

In clinical practice most patients' first concern is esthetics, soft tissue grafting is becoming routine in clinical practice to make up for the deficiency in supra-crestal tissue dimension that typically follows tooth loss. The edentulous site experiences major qualitative and quantitative changes because of a number of sequential events that occur after tooth extraction. Ridge dimensional alterations of the underlying bone and the soft tissue architecture overlaying it are the consequence of the socket healing process. To maintain the remaining teeth, aesthetic jaw support and optimal food chewing, lost teeth must be replaced. The teeth adjacent to and opposing a missing tooth will eventually tip, shift, and migrate, disrupting normal function. One integral part of the new strategy for treating periodontal diseases is thought to be surgical periodontal operations. Soft tissue grafting has become more frequently utilized to improve the aesthetics of teeth and dental implant sites by treating mucogingival abnormalities, restoring an appropriate width of keratinized tissue, and enhancing tissue thickness. SCTG has its own limitations, such as lack of graft availability, need for a second surgical site, proximity to palatine neurovascular complex and unaesthetic tissue contour at the recipient site. Due to these limitations, investigations on more regenerative nature techniques have been explored such as PRF, Using PRF instead of SCTG has the added value of decreasing discomfort and postoperative pain after the surgical procedure due to having additional donor site, To the best of our knowledge testing multi-layer PRF against SCTG in pontic site augmentation was never done before.

Conditions

Pontic Site Augmentation; Connective Tissue Graft

Keywords

Pontic site augmentation

Outcome Measures

Primary Outcomes (1)

• Keratinized tissue thickness

  6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Procedure: Pontic site augmentation with sub-epithelial connective tissue graft.

Test

EXPERIMENTAL

Procedure: Pontic site augmenation using multi-layered platelet rich fibrin

Interventions

Pontic site augmentation with sub-epithelial connective tissue graft. PROCEDURE

Pontic site augmentation with sub-epithelial connective tissue graft.

Control

Pontic site augmenation using multi-layered platelet rich fibrin PROCEDURE

Pontic site augmenation using multi-layered platelet rich fibrin

Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults from the age of 18 - 40 years
• Patients with missing maxillary teeth/tooth in the area from 2nd premolar to 2nd premolar with ridge defect according to Seibert classification (Class I, II and III).
• Intact gingival tissue with at least 2mm keratinized tissue.
• Periodontally healthy patients.
• Patients accepts to provide informed consent.

You may not qualify if:

• Smokers.
• Pregnant females.
• Handicapped and mentally challenged patients.
• Systemic disease compromising wound healing.
• Active soft tissue infection

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Joseph Osama Kostandy, Bachelor Degree of dentsitry

CONTACT

+2001226718007; joseph.osama@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate candidate in Cairo university

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04