Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
130 participants
INTERVENTIONAL
2023-02-28
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. covered with a free palatal graft
3. covered with pedical palatal graft
4. covered with a collagen membrane
5. covered with a non-resorbable high-density polytetrafluoroethylene membrane.
TREATMENT
DOUBLE
Study Groups
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spontaneous healing
No treatment after tooth extraction
No interventions assigned to this group
Bone particle + subepithelial connective tissue graft
Alveolar ridge preservation grafted with bone particle and covered with a subepithelial connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with a subepithelial connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with a collagen membrane
Alveolar ridge preservation
grafted with bone particle and covered with a Cytoplast
Bone particle + Vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservation grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with a subepithelial connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with a collagen membrane
Alveolar ridge preservation
grafted with bone particle and covered with a Cytoplast
Bone particle + collagen membrane
Alveolar ridge preservation grafted with bone particle and covered with a collagen membrane
Alveolar ridge preservation
grafted with bone particle and covered with a subepithelial connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with a collagen membrane
Alveolar ridge preservation
grafted with bone particle and covered with a Cytoplast
Bone particle + Cytoplast
Alveolar ridge preservation grafted with bone particle and covered with a Cytoplast.
Alveolar ridge preservation
grafted with bone particle and covered with a subepithelial connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with a collagen membrane
Alveolar ridge preservation
grafted with bone particle and covered with a Cytoplast
Interventions
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Alveolar ridge preservation
grafted with bone particle and covered with a subepithelial connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservation
grafted with bone particle and covered with a collagen membrane
Alveolar ridge preservation
grafted with bone particle and covered with a Cytoplast
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
20 Years
ALL
Yes
Sponsors
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Tri-Service General Hospital
OTHER
Responsible Party
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Cheng-En Sung
Assistant professor
Locations
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Tri-Service General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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A202305015
Identifier Type: -
Identifier Source: org_study_id
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