Tooth LossNCT03410251
Long- Term Follow-up of Extraction Socket Management
An observational study of Tooth Loss, run by University of Liege.
Trial summary
Twenty-nine patients needing single tooth replacement in aesthetic area were treated by extraction and socket preservation with saddle connective tissue graft between September 2009 and February 2012. Computed Tomography scan were taken at baseline just after the surgery and 3 months later. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Socket preservation
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jul 2017
- Phase
- Observational
- 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
Study population: Patients were recruited from the Department of Periodontology and Oral Surgery of the University of Liège, Belgium.
Who may be able to join
- Good general health (ASA 1, 2)
- Controlled periodontitis
- >18 years of age or signed consent by the parents
- Smoking history of<10 cigarettes per day
- Signed informed consent.
Who cannot join
- Pregnancy or lactation
- Concurrent participation in another trial
- Bone disease or the use of medications that interfered with bone metabolism
- History of head and neck radio- therapy
- Presence of dehiscence or fenestration on bone wall of the socket.
About this study
Official title: Long- Term Follow-up of Extraction Socket Management : Clinical Outcomes and Hard Tissue Changes
Twenty-nine patients needing single tooth replacement in aesthetic area were treated by extraction and socket preservation with saddle connective tissue graft between September 2009 and February 2012. Computed Tomography scan were taken at baseline just after the surgery and 3 months later. Long- term evaluation of this particular socket management procedure was evaluated by recalling successfully seventeen of theses patients in June 2016. At this time, a clinical and radiographical consultation was done and Cone Beam CT was taken. Horizontal and vertical bone dimensional changes were then assessed thanks to 3D imaging analysis and esthetic and implants outcomes were evaluated.
- Conditions
- Tooth Loss
- Being tested
- Socket preservation
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservationProcedure or surgery
Teeth were extracted atraumatically and without flap release in patients who have received prophylactic antibiotherapy and local anaesthesia. After checking the integrity of the buccal and palatal bone plate, biomaterial (Bio-Oss®) was introduced into the socket. A connective tissue graft harvested from the palate was inserted and sutured in buccal and palatal pouches in order to cover the socket.
chlorhexidine spray (0.12%) twice a day and Ibuprofen 600 mg three times/ day were prescribed whereas antibiotics were continued for 5 days. Tooth brushing was banned at the extraction site for 10 days and sutures were removed 10 days after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Alveolar bone remodeling to 3 months and 6 year: horizontal measurements (based on CBCT, in mm)
The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. Palatal horizontal measurements were calculated by subtracting the buccal horizontal measurements from the total horizontal measurements.
Measured: Baseline, 3 months, 6 years
Changes from Baseline Alveolar bone remodeling to 3 months and 6 year : vertical measurements (based on CBCT, in mm)
The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. One vertical measurement was taken on the buccal side, in parallel to the vertical reference line at mid distance between the buccal wall and reference line.
Measured: Baseline, 3 months, 6 years
Secondary outcomes (4)
Esthetic outcomes (PES questionnaire)
At the cross- sectional long- term evaluation, to analyse the esthetic outcomes of the surgical procedure, the pink esthetic score (PES) was assessed (Fürhauser et al. 2005)
Measured: Approximatively 6 years
Esthetic outcomes (VAS questionnaire)
A VAS questionnaire was given to the patients in order to collect their opinion about the esthetic results.
Measured: Approximatively 6 years
Implant survival rate (based on criteria of Buser et al., 1990)
Success was defined according to the criteria of Buser et al., 1990 which are 1. absence of suppuration (recurring peri implant infection) 2. absence of persistent complaints like pain, foreign body sensation and/or dysesthesia 3. absence of continuous radioluncency area around the implant 4. absence of implant mobility.
Measured: Approximatively 6 years
Peri-implant bone levels (based on periapical radiography, in mm)
The peri- implant bone levels were assessed on periapical radiography using the parallell technique: the distance between the implant shoulder and the first bone to implant contact (DIB) was measured at the mesial and distal aspects using the specific software Image J64 (National Institutes of Health, Bethesda, MD, USA).
Measured: Approximatively 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study startJun 2016
- Primary completionJul 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 17 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
- NCT03410251
- Sponsor's protocol ID
- H2016-2 ExMA5
- Status last verified
- Jan 2018
- First submitted
- 26 Jul 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long- Term Follow-up of Extraction Socket Management : Clinical Outcomes and Hard Tissue Changes
- ClinicalTrials.gov ID
- NCT03410251
- Acronym / sponsor ID
- H2016-2 ExMA5
- Conditions
- Tooth Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Jan 2018 (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.
Twenty-nine patients needing single tooth replacement in aesthetic area were treated by extraction and socket preservation with saddle connective tissue graft between September 2009 and February 2012. Computed Tomography scan were taken at baseline just after the surgery and 3 months later. Long- term evaluation of this particular socket management procedure was evaluated by recalling successfully seventeen of theses patients in June 2016. At this time, a clinical and radiographical consultation was done and Cone Beam CT was taken. Horizontal and vertical bone dimensional changes were then assessed thanks to 3D imaging analysis and esthetic and implants outcomes were evaluated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from the Department of Periodontology and Oral Surgery of the University of Liège, Belgium.
Key inclusion criteria (5 listed)
- Good general health (ASA 1, 2)
- Controlled periodontitis
- >18 years of age or signed consent by the parents
- Smoking history of<10 cigarettes per day
- Signed informed consent.
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Concurrent participation in another trial
- Bone disease or the use of medications that interfered with bone metabolism
- History of head and neck radio- therapy
- Presence of dehiscence or fenestration on bone wall of the socket.
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 |
|---|---|---|
| Socket preservationTeeth were extracted atraumatically and without flap release in patients who have received prophylactic antibiotherapy and local anaesthesia. After checking the integrity of the buccal and palatal bone plate, biomaterial (Bio-Oss®) was introduced into the socket. A connective tissue graft harvested from the palate was inserted and sutured in buccal and palatal pouches in order to cover the socket. chlorhexidine spray (0.12%) twice a day and Ibuprofen 600 mg three times/ day were prescribed whereas antibiotics were continued for 5 days. Tooth brushing was banned at the extraction site for 10 days and sutures were removed 10 days after surgery. | Procedure or surgery | – |
Primary outcome
Changes from Baseline Alveolar bone remodeling to 3 months and 6 year: horizontal measurements (based on CBCT, in mm)
Time frame: Baseline, 3 months, 6 years
The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. Palatal horizontal measurements were calculated by subtracting the buccal horizontal measurements from the total horizontal measurements.
Changes from Baseline Alveolar bone remodeling to 3 months and 6 year : vertical measurements (based on CBCT, in mm)
Time frame: Baseline, 3 months, 6 years
The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. One vertical measurement was taken on the buccal side, in parallel to the vertical reference line at mid distance between the buccal wall and reference line.
4 secondary outcomes
Esthetic outcomes (PES questionnaire)
Time frame: Approximatively 6 years
Esthetic outcomes (VAS questionnaire)
Time frame: Approximatively 6 years
Implant survival rate (based on criteria of Buser et al., 1990)
Time frame: Approximatively 6 years
Peri-implant bone levels (based on periapical radiography, in mm)
Time frame: Approximatively 6 years
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 25 Jan 2018.
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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?
An observational study of Tooth Loss, 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 5 inclusion and 5 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 25 Jan 2018. 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.
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?
Changes from Baseline Alveolar bone remodeling to 3 months and 6 year: horizontal measurements (based on CBCT, in mm) (time frame: Baseline, 3 months, 6 years). The study lists 2 primary outcomes in all. 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 25 Jan 2018; AzTrials last refreshed its copy on 31 Oct 2026.