Clinical trial NCT05892016: Ridge Preservation Using Different Techniques
Official title: Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alveolar Ridge Augmentation
Connective Tissue
Tooth Extraction
Membranes; Retained
Keywords: Alveolar Ridge Preservation Connective tissue graft
Tooth extraction
Membranes
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. spontaneous healing (control) Alveolar ridge preservation grafted with bone particle and
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.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Soft tissue alternation
timeFrame: up to 12 months
measure: Hard tissue alternation
timeFrame: up to 12 months
Secondary outcomes:
measure: Keratinized tissue width changes
timeFrame: up to 12 months
measure: Visual Analogue Scale
timeFrame: 14 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: