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

NCT06621498 | Completed

• 1 other identifier: 118/23.06.2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Extraction Socket Healing; Ridge Preservation

Keywords

ridge preservation; post-extraction healing; post-extraction resorption; dense polytetrafluoroethylene membrane; free gingival graft; platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Ridge preservation with dense polytetrafluoroethylene membrane

EXPERIMENTAL

Tooth extraction and ridge prservation with dense PTFE membrane to cover the socket was used in this group.

Procedure: Ridge preservation technique

Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma

EXPERIMENTAL

Tooth extraction and ridge prservation with dense PTFE membrane and autologous PRP was used in this group.

Procedure: ridge preservation

Ridge preservation with free gingival grafts

EXPERIMENTAL

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

Control group

NO INTERVENTION

Tooth extraction without ridge preservation.

Interventions

Ridge preservation technique PROCEDURE

Tooth extraction, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing.

Also known as: ridge preservation, socket preservation

Ridge preservation with dense polytetrafluoroethylene membrane

ridge preservation PROCEDURE

Tooth extraction, socket filling with PRP, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing.

Also known as: socket preservation

Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• There are local contraindications:
• insufficient volume of bone after the extraction to carry out RP;
• acute inflammatory disease or tumor process in the area;
• Lack of informed consent.

Sponsors & Collaborators

• Medical University of Varna: lead

Study Sites (1)

Medical University Varna

Varna, 9002, Bulgaria

Location

Study Officials

• Stefan V Peev, DsC

  Medical University of Varna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: June 23, 2022
• Primary Completion: March 20, 2023
• Study Completion: April 12, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)