Tooth LostPhase 4NCT02753153
Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®
A Phase 4 study testing Test surgical protocol and Socket preservation in people with Tooth Lost, run by University of Liege.
Trial summary
This study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas: 3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at the time of implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Lost
- What is being tested?
- Test surgical protocol and Socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients needing an extraction in the aesthetic area to be replace with an implant (incisive, canine or premolar)
- Good general health (ASA 1, 2)
- Controlled periodontitis
- No age restriction
Who cannot join
- Extraction socket with buccal bone defect / buccal bone wall dehiscence
- Smokers > 10 cigarettes per day
- Immune system disease
- Bone disease or treatment by medicines interfering with bone metabolism
About this study
Official title: Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®: A Randomized Controlled Trial
This study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas:
- 3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at the time of implant placement. (Outcomes 1: Hard tissues analyses )
- Impressions, models and 3D analyses of the treated area allowed studying external soft tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues analyses )
- Conditions
- Tooth Lost
- Being tested
- Control surgical protocol, Test surgical protocol, Socket preservation
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control surgical protocolProcedure or surgery
A connective tissue graft will be harvested to the palate or posterior maxilla tuberosity. The dimension of the graft will be previously calculated according to the socket dimensions. The harvesting site will be made with a single edge incision and sutured with 4.0 silk (uninterrupted suture). The connective tissue graft will be reshaped if necessary to be 1-2mm thick and inserted into buccal pouch and sutured with 2 vertical interrupted sutures to be stabilized on the buccal aspect.
The connective tissue graft is then positioned to caver the socket and inserted and sutured in the palatal pouch also by the means of vertical interrupted sutures (polypropylen 6.0).
Test surgical protocolProcedure or surgery
The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction.
Socket preservationProcedure or surgery
An atraumatic extraction will be performed in order to preserve the socket bone wall as well as the cervical soft tissues.
Split- thickness pockets will be performed 5-6 mm deep buccally and 3-4 mm deep palatally preserving interproximal papillae. The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction. At this level of the surgery, the randomization envelope will be open and either the control or the test surgical protocol will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Mucograft®, Geistlich Biomaterials | Experimental | A Mucograft membrane will be used in state of a connective tissue graft. The dimension of the Mucograft® will be previously calculated according to the site dimensions and inserted into buccal pouch and sutured to be stabilized on the buccal aspect. The membrane is then positioned to cover the socket and inserted and sutured in the palatal pouch by the means of vertical interrupted sutures Receives: Procedure: Test surgical protocol; Procedure: Socket preservation |
| Soft tissue graft | Active comparator | Not described Receives: Procedure: Control surgical protocol; Procedure: Socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone remodeling of the buccal and palatal walls using radiographic measurements
Bone remodeling of the buccal and palatal walls will be measured in cone beam computerized tomography (CBCT) on the day of extraction, at 3 months after implant placement.
Measured: 1year
Secondary outcomes (1)
Soft tissue contours measurements by 3D image analyses.
Models from the different time points are scanned using 3D-Laser-Scanner and Software (Metalor). 3D reconstructions are matched in order to evaluate 3D and 2D volume changes in extraction sites from baseline to implant placement.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LostStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753153
- Sponsor's protocol ID
- H2010-1
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02753153
- Acronym / sponsor ID
- H2010-1
- Conditions
- Tooth Lost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Apr 2016 (estimated)
- 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.
This study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas:
- 3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at the time of implant placement. (Outcomes 1: Hard tissues analyses )
- Impressions, models and 3D analyses of the treated area allowed studying external soft tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues analyses )
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucograft®, Geistlich Biomaterials | Experimental | Procedure: Test surgical protocol, Procedure: Socket preservationA Mucograft membrane will be used in state of a connective tissue graft. The dimension of the Mucograft® will be previously calculated according to the site dimensions and inserted into buccal pouch and sutured to be stabilized on the buccal aspect. The membrane is then positioned to cover the socket and inserted and sutured in the palatal pouch by the means of vertical interrupted sutures |
| Soft tissue graft | Active comparator | Procedure: Control surgical protocol, Procedure: Socket preservation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients needing an extraction in the aesthetic area to be replace with an implant (incisive, canine or premolar)
- Good general health (ASA 1, 2)
- Controlled periodontitis
- No age restriction
Key exclusion criteria (4 listed)
- Extraction socket with buccal bone defect / buccal bone wall dehiscence
- Smokers > 10 cigarettes per day
- Immune system disease
- Bone disease or treatment by medicines interfering with bone metabolism
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 |
|---|---|---|
| Control surgical protocolA connective tissue graft will be harvested to the palate or posterior maxilla tuberosity. The dimension of the graft will be previously calculated according to the socket dimensions. The harvesting site will be made with a single edge incision and sutured with 4.0 silk (uninterrupted suture). The connective tissue graft will be reshaped if necessary to be 1-2mm thick and inserted into buccal pouch and sutured with 2 vertical interrupted sutures to be stabilized on the buccal aspect. The connective tissue graft is then positioned to caver the socket and inserted and sutured in the palatal pouch also by the means of vertical interrupted sutures (polypropylen 6.0). | Procedure or surgery | Soft tissue graft |
| Test surgical protocolThe filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction. | Procedure or surgery | Mucograft®, Geistlich Biomaterials |
| Socket preservationAn atraumatic extraction will be performed in order to preserve the socket bone wall as well as the cervical soft tissues. Split- thickness pockets will be performed 5-6 mm deep buccally and 3-4 mm deep palatally preserving interproximal papillae. The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction. At this level of the surgery, the randomization envelope will be open and either the control or the test surgical protocol will be applied. | Procedure or surgery | Mucograft®, Geistlich Biomaterials, Soft tissue graft |
Primary outcome
Bone remodeling of the buccal and palatal walls using radiographic measurements
Time frame: 1year
Bone remodeling of the buccal and palatal walls will be measured in cone beam computerized tomography (CBCT) on the day of extraction, at 3 months after implant placement.
1 secondary outcome
Soft tissue contours measurements by 3D image analyses.
Time frame: 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Test surgical protocol and Socket preservation in people with Tooth Lost, run by University of Liege.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone remodeling of the buccal and palatal walls using radiographic measurements (time frame: 1year). 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 27 Apr 2016.