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Clinical Trials/NCT05892016
NCT05892016
Enrolling By Invitation
Not Applicable

Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques

Tri-Service General Hospital1 site in 1 country130 target enrollmentFebruary 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Ridge Augmentation
Sponsor
Tri-Service General Hospital
Enrollment
130
Locations
1
Primary Endpoint
Soft tissue alternation
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief Summary

Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques

Background:

Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. In an attempt to attenuate the loss of hard and soft tissue after tooth loss, alveolar ridge preservation (ARP) immediately after complete tooth extraction could minimize the need for ancillary ridge augmentation or soft tissue grafting. Different techniques and barrier membranes has been proposed to achieve the sealing of extraction socket.

Aim:

To investigate the effect of different techniques and barrier membranes for the soft tissue contour and morphological change of alveolar ridge after ARP

Methods:

The study was designed as a randomized controlled trial and recruited patients, who require ARP for the purpose of implant placement or prosthodontic rehabilitation. After the tooth extraction, patients were randomly allocated to one of the following groups: ridge preservation with a xenogeneic bone substitute and (a) spontaneous healing (control), (b) covered with a free palatal graft, (c) or covered with pedical palatal graft, (d) covered with a collagen membrane, (e) covered with a non-resorbable high-density polytetrafluoroethylene membrane. 2 weeks, 4 weeks, 12 weeks, and 24 weeks following tooth extraction and ARP, clinical profilometric and radiographic evaluations were performed to analyze the change of hard and soft tissue contour. Moreover, and the need for additional guided bone regeneration (GBR) or soft tissue augmentation were assessed prior implants or fixed prosthesis placement.

Registry
clinicaltrials.gov
Start Date
February 28, 2023
End Date
March 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheng-En Sung

Assistant professor

Tri-Service General Hospital

Eligibility Criteria

Inclusion Criteria

  • \>20 years old
  • No contraindications for invasive dental procedures.
  • Not pregnant.
  • Teeth need to be extracted due to malocclusion or broken teeth.
  • Requires dental implant or denture fabrication after tooth extraction.
  • Healthy soft tissue (probing bleeding index \<20%, plaque index \<20%).
  • At least 2mm of keratinized gingiva on the buccal and lingual sides.
  • No need for simultaneous bone augmentation surgery during implant placement.
  • Willing to participate in and sign the consent form for this trial.

Exclusion Criteria

  • Poor oral hygiene maintenance.
  • Uncontrolled periodontal disease.
  • Heavy smoker (smokes \>20 cigarettes per day).
  • Uncontrolled diabetes.
  • Alcohol abuse.
  • Currently receiving medication treatment affecting wound healing (osteoporosis medication, radiation or chemotherapy).

Outcomes

Primary Outcomes

Soft tissue alternation

Time Frame: up to 12 months

cone-beam computed tomography data and STereoLithography files are superimposed to measure the soft tissue dimensions.

Hard tissue alternation

Time Frame: up to 12 months

cone-beam computed tomography data and STereoLithography files are superimposed to measure the hard tissue dimensions.

Secondary Outcomes

  • Keratinized tissue width changes(up to 12 months)
  • Visual Analogue Scale(14 days)

Study Sites (1)

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