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Guided Bone Regeneration in Alveolar Socket

NCT05577663 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-10-17

No results posted yet for this study

Summary

Following tooth extraction, volumetric changes in the soft and hard tissues of the extraction site are expected to occur with considerable resorption of the alveolar bone in both the vertical and the horizontal dimensions. These changes may complicate surgical implant placement and may also compromise the outcome of the prosthetic reconstruction. Various treatment approaches have been introduced aiming to preserve the dimensions of the alveolar ridge at the extraction site and facilitate optimal implant placement.

This prospective randomized controlled trial aims to determine the efficacy of alveolar ridge preservation utilizing two different socket seal approaches compared to spontaneous healing to stabilize the blood clot within the postextraction socket. Thirty-six subjects will be randomly allocated into one of the three treatment groups. Group-A: Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0. Group-B: Extraction of the tooth and placement of a Free Gingival Graft stabilized with resorbable suture PGA 5/0. Group-C: Extraction of the tooth and placement of the Polylactic-Glycolic Acid membrane stabilized with resorbable suture PGA 5/0. After the initial examination for screening, subjects will be assessed at baseline-extraction day- and after 1, 2, and 6 weeks, and 3 months. The changes of the alveolar crest will be determined in height and width, in addition to volumetric changes in the soft tissues, and the width of keratinized tissues. The wound healing process will be visually assessed.

Conditions

  • Alveolar Bone Resorption

Interventions

OTHER

Routine treatment of the extraction socket

Suturing of the extraction socket with resorbable suture PGA 5/0 in order to protect the blood clot

PROCEDURE

Socket seal technique by a free gingival graft

Placement of a free gingival graft in the socket opening in order to protect and stabilize the blood clot followed by suturing

PROCEDURE

Socket seal technique using a synthetic resorbable membrane

Placement of a synthetic barrier in the socket opening in order to protect and stabilize the blood clot followed by suturing

Sponsors & Collaborators

  • University Paul Sabatier of Toulouse

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-03-30
Completion
2024-12-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05577663 on ClinicalTrials.gov