Tooth ExtractionNCT04802148
Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.
A study testing membrane guided regeneration and collagen plug in people with Tooth Extraction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The resorption of alveolar ridge after tooth extraction develop difficulty in restoring the extraction area with implant or bridge. Therefore, try to preserve the alveolar ridge width and height at extraction socket and gaining its bone volume in maximal is worth for clinical investigation. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- membrane guided regeneration and collagen plug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>20
- according to periapical film, the bone defect over bucco-lingual and mesio-distal direction less than 50%
- patient agreed to undergo implant therapy after tooth extraction
Who cannot join
- systemic diseases which will affect wound healing (ex. Diebetes)
- heavy smoker (10 cigarette/day)
- patient who underwent oral-maxillary surgery or who diagnosed with oral cancer
- patient who is pregnant or who is breast-feeding
- patient who is allergic to Lidocaine
- patient who cannot cooperate the study design
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
CHEN-YING WANG, PhD
About this study
The resorption of alveolar ridge after tooth extraction develop difficulty in restoring the extraction area with implant or bridge. Therefore, try to preserve the alveolar ridge width and height at extraction socket and gaining its bone volume in maximal is worth for clinical investigation. There are several method to deal with alveolar ridge preservation (ARP), the most popular way for its approach, the trend is toward to minimally invasive treatment. Alveolar ridge preservation which is done with open-healed wound without primary closure is the key for minimally invasive approach.
This three-armed randomized clinical trial would like to determine the effect of applying ribose cross-linked collagen membrane without primary flap closure in molar extraction sockets for alveolar ridge preservation. The procedure is for implant site development.
Three groups were designed as test group1 was grafted with freeze dried bone allograft (FDBA) and covered by ribose cross-linked collagen membrane (OSSIX® PLUS). In test group2 sockets filled with collagen plug(Teruplug®) and sockets healed naturally as control group. Cone-beam computed tomography(CBCT) scans are obtained immediately and 4 months after ARP as the primary outcome and secondary outcome. A biopsy from implant site and histomorphometric analysis will be done as well. The change of marginal bone level and the width/height of keratinized mucosa are measured.
- Conditions
- Tooth Extraction
- Being tested
- membrane guided regeneration, collagen plug
- Keywords
- ridge preservation, tooth extraction, collagen membrane, cone-beam computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
membrane guided regenerationProcedure or surgery
after tooth extraction, the socket was filled with membrane and graft (FDBA)
collagen plugProcedure or surgery
after tooth extraction, the socket was filled with collagen plug
| Study group | Role | What they receive |
|---|---|---|
| control (natural healing) | No intervention | Extraction socket is naturally healed |
| Test 1 (membrane guided regeneration) | Experimental | Extraction socket is filled with graft (FDBA) and covered with collagen membrane Receives: Procedure: membrane guided regeneration |
| Test 2 (collagen plug) | Active comparator | Extraction socket is filled with a collagen plug Receives: Procedure: collagen plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar ridge width and height in three plane
mesure with CBCT
Measured: four months after surgery
Secondary outcomes (1)
gingival thickness
measure with CBCT and clinical observation
Measured: four months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start15 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802148
- Sponsor's protocol ID
- 202004006RINB
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04802148
- Acronym / sponsor ID
- 202004006RINB
- Conditions
- Tooth Extraction
- Keywords
- ridge preservation, tooth extraction, collagen membrane, cone-beam computed tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The resorption of alveolar ridge after tooth extraction develop difficulty in restoring the extraction area with implant or bridge. Therefore, try to preserve the alveolar ridge width and height at extraction socket and gaining its bone volume in maximal is worth for clinical investigation. There are several method to deal with alveolar ridge preservation (ARP), the most popular way for its approach, the trend is toward to minimally invasive treatment. Alveolar ridge preservation which is done with open-healed wound without primary closure is the key for minimally invasive approach.
This three-armed randomized clinical trial would like to determine the effect of applying ribose cross-linked collagen membrane without primary flap closure in molar extraction sockets for alveolar ridge preservation. The procedure is for implant site development.
Three groups were designed as test group1 was grafted with freeze dried bone allograft (FDBA) and covered by ribose cross-linked collagen membrane (OSSIX® PLUS). In test group2 sockets filled with collagen plug(Teruplug®) and sockets healed naturally as control group. Cone-beam computed tomography(CBCT) scans are obtained immediately and 4 months after ARP as the primary outcome and secondary outcome. A biopsy from implant site and histomorphometric analysis will be done as well. The change of marginal bone level and the width/height of keratinized mucosa are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control (natural healing) | No intervention | –Extraction socket is naturally healed |
| Test 1 (membrane guided regeneration) | Experimental | Procedure: membrane guided regenerationExtraction socket is filled with graft (FDBA) and covered with collagen membrane |
| Test 2 (collagen plug) | Active comparator | Procedure: collagen plugExtraction socket is filled with a collagen plug |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>20
- according to periapical film, the bone defect over bucco-lingual and mesio-distal direction less than 50%
- patient agreed to undergo implant therapy after tooth extraction
Key exclusion criteria (6 listed)
- systemic diseases which will affect wound healing (ex. Diebetes)
- heavy smoker (10 cigarette/day)
- patient who underwent oral-maxillary surgery or who diagnosed with oral cancer
- patient who is pregnant or who is breast-feeding
- patient who is allergic to Lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| membrane guided regenerationafter tooth extraction, the socket was filled with membrane and graft (FDBA) | Procedure or surgery | Test 1 (membrane guided regeneration) |
| collagen plugafter tooth extraction, the socket was filled with collagen plug | Procedure or surgery | Test 2 (collagen plug) |
Primary outcome
alveolar ridge width and height in three plane
Time frame: four months after surgery
mesure with CBCT
1 secondary outcome
gingival thickness
Time frame: four months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Tooth Extraction
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing membrane guided regeneration and collagen plug in people with Tooth Extraction, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Ying Wang, PHD (+886-972-651-897, jybean@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alveolar ridge width and height in three plane (time frame: four months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.