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

NCT ID: NCT06621498

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2023-04-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ridge preservation with dense polytetrafluoroethylene membrane

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

Group Type: EXPERIMENTAL

Ridge preservation technique

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

ridge preservation

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

ridge preservation

Intervention Type: PROCEDURE

Tooth extraction, full-thickness graft harversting and socket sealing with it.

Control group

Tooth extraction without ridge preservation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ridge preservation technique

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

Intervention Type: PROCEDURE

ridge preservation

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

Intervention Type: PROCEDURE

ridge preservation

Tooth extraction, full-thickness graft harversting and socket sealing with it.

Intervention Type: PROCEDURE

Other Intervention Names

ridge preservation; socket preservation; socket preservation; socket preservation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Varna

OTHER

Sponsor Role: lead

Responsible Party

Ralitsa Yotsova

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan V Peev, DsC

Role: PRINCIPAL_INVESTIGATOR

Medical University of Varna

Locations

Medical University Varna

Varna, , Bulgaria

Countries

Bulgaria

Other Identifiers

118/23.06.2022

Identifier Type: -

Identifier Source: org_study_id