RecruitingNot ApplicableNCT05577663

Guided Bone Regeneration in Alveolar Socket

Guided Bone Regeneration in Alveolar Socket Using a Synthetic Resorbable Membrane. a Randomized Controlled Trial


Sponsor

Aristotle University Of Thessaloniki

Enrollment

39 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether guided bone regeneration (a technique that places a barrier membrane in the socket after a tooth is pulled) helps preserve the jawbone and shape of the gum for future dental implants or other restorations. It compares this technique to normal tooth extraction without extra bone preservation. You may be eligible if: - You are 18 to 65 years old - You are having a single tooth extracted - The tooth has less than 50% bone loss around it - You are able to provide informed consent You may NOT be eligible if: - You have systemic diseases that interfere with surgery or wound healing (e.g., uncontrolled diabetes) - You take medications that affect bone metabolism - You are pregnant or breastfeeding - You need multiple teeth extracted - You are missing the teeth on both sides of the extraction site - You have lost the outer (buccal) bone wall due to gum disease or a difficult extraction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRoutine treatment of the extraction socket

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

PROCEDURESocket 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

PROCEDURESocket 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


Locations(1)

Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology

Thessaloniki, Greece

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NCT05577663


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