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

M

Medical University of Varna

Status

Completed

Conditions

Post-Extraction Socket Healing
Ridge Preservation

Treatments

Procedure: Ridge preservation technique
Procedure: ridge preservation

Study type

Interventional

Funder types

Other

Identifiers

NCT06621498
118/23.06.2022

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 4 patient groups

Ridge preservation with dense polytetrafluoroethylene membrane
Experimental group
Description:
Tooth extraction and ridge prservation with dense PTFE membrane to cover the socket was used in this group.
Treatment:
Procedure: Ridge preservation technique
Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma
Experimental group
Description:
Tooth extraction and ridge prservation with dense PTFE membrane and autologous PRP was used in this group.
Treatment:
Procedure: ridge preservation
Procedure: ridge preservation
Ridge preservation with free gingival grafts
Experimental group
Description:
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.
Treatment:
Procedure: ridge preservation
Procedure: ridge preservation
Control group
No Intervention group
Description:
Tooth extraction without ridge preservation.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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