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

Inclusion Criteria3

  • Referrals for a single tooth extraction
  • Periodontal destruction less than 50% of tooth support
  • Signed inform consent form

Exclusion Criteria6

  • Systematic diseases, contradicting surgical procedures and compromise wound healing (i.e. uncontrolled diabetes)
  • Medication that interferes with bone metabolism
  • Pregnancy or lactation
  • Multiple extractions
  • Absence of adjacent teeth
  • Loss of buccal bone, either due to periodontal disease or because of traumatic extraction

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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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