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

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.

Study Overview

• Status: Completed
• Conditions: Ridge Preservation; Post-Extraction Socket Healing
• Intervention / Treatment: Procedure: Ridge preservation technique; Procedure: ridge preservation; Procedure: ridge preservation

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Varna, Bulgaria, 9002
    • Medical University Varna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ridge preservation with dense polytetrafluoroethylene membrane; Tooth extraction and ridge prservation with dense PTFE membrane to cover the socket was used in this group.	Procedure: Ridge preservation technique; Tooth extraction, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing.; Other Names: ridge preservation; socket preservation
Experimental: Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma; Tooth extraction and ridge prservation with dense PTFE membrane and autologous PRP was used in this group.	Procedure: ridge preservation; Tooth extraction, socket filling with PRP, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing.; Other Names: socket preservation; Procedure: ridge preservation; Tooth extraction, full-thickness graft harversting and socket sealing with it.; Other Names: socket preservation
Experimental: Ridge preservation with free gingival grafts; 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.	Procedure: ridge preservation; Tooth extraction, socket filling with PRP, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing.; Other Names: socket preservation; Procedure: ridge preservation; Tooth extraction, full-thickness graft harversting and socket sealing with it.; Other Names: socket preservation
No Intervention: Control group; Tooth extraction without ridge preservation.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Varna
• Investigators: Principal Investigator: Stefan V Peev, DsC, Medical University of Varna

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: free gingival graft; platelet-rich plasma; ridge preservation; post-extraction healing; post-extraction resorption; dense polytetrafluoroethylene membrane
• Other Study ID Numbers: 118/23.06.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It has not been approved by the Research Ethics Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No