Ridge Preservation Using Guided Regenaration, Platelet-rich Plasma and Free Gingival Grafts

Not Applicable

Completed

• Conditions: Post-Extraction Socket Healing; Ridge Preservation
• Interventions: Procedure: Ridge preservation technique; Procedure: ridge preservation

• Registration Number: NCT06621498
• Lead Sponsor: Medical University of Varna

Brief Summary

The goal of this clinical trial is to learn if ridge preservation methods with dense polytetrafluoroethylene membranes, with d-PTFE membranes and platelet-rich plasma, and with free gingival grafts can reduce vertical resorption of the post-extraction socket walls.

Researchers compared each experimental group to a control group (unassisted socket healing). Participants were randomly allocated to one of the four groups.

Cone-beam computed tomography was performed after the procedure and 3 months post-operatively to evaluate the vertical socket wall resorption.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Primary Completion: 2023-03-20
• Study Completion: 2023-04-12
• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients in the age group 18-65 years;
2. Patients in good general condition;
3. Patients requiring extraction of premolars or molars;
4. Patients in whom restoration of the missing tooth with a dental implant and/or prosthetic construction is planned;
5. Signed informed consent to participate in the study.

Exclusion Criteria

1. Patients with contraindications for general surgical treatment:

   • patients with uncontrolled arterial hypertension;
   • patients with uncontrolled metabolic diseases;
   • patients with AMI in the last 6 months;
   • patients on hemodialysis treatment;
   • patients who underwent chemotherapy and/or radiotherapy in the last year;
   • patients on immunosuppressive therapy;
   • patients on anti-resorptive and anti-angiogenic therapy;
   • patients with concomitant acute diseases at the time of the study;
   • patients with proven psychiatric diseases;
   • pregnancy.

2. There are local contraindications:

   • insufficient volume of bone after the extraction to carry out RP;
   • acute inflammatory disease or tumor process in the area;

3. Lack of informed consent.

4. Lack of patient motivation for the treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridge preservation with dense polytetrafluoroethylene membrane	Ridge preservation technique	Tooth extraction and ridge prservation with dense PTFE membrane to cover the socket was used in this group.
Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma	ridge preservation	Tooth extraction and ridge prservation with dense PTFE membrane and autologous PRP was used in this group.
Ridge preservation with free gingival grafts	ridge preservation	Tooth extraction and ridge prservation with autologous free gingival grafts as a method for socket sealing was used. Donor sites were the hard palate and the maxillary tuberosity.

Primary Outcome Measures

Name	Time	Method
Vertical post-extraction resorption of the socket walls	3 months	Each socket wall is measured using CBCT right after the extraction and after 3 months to assess the vertical resorption.

Trial Locations

Locations (1)

Medical University Varna; 🇧🇬 Varna, Bulgaria