Bone RegenerationNCT04338139
Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration
A study testing bone regeneration in people with Bone Regeneration, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2020to 30 Jul 2021
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >18 years old
- Smoking <10 cigarettes/day (Light smoker)
- Good general health.
- Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding.
Who cannot join
- A pregnant or nursing mother
- Pathologies that may impair bone healing: diabetes, autoimmune diseases, corticosteroids, chemotherapy.
- Orthodontic treatment in progress or planned
- Adjacent risk teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration: a Human Study
to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study:
- Pre-operatively:
- cone beam computed tomography CBCT
- 1 minute mouthwash with a 0.12% Chlorhexidine solution
- Full thickness muco-periosteal flap and ridge curettage.
- Drilling and implant placement (any implant system)
- Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane.
- Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material.
- Post-operatively:
- Medication:
- Amoxicilline (1g) or Clindamycine (300mg)
- Analgesic, (paracetamol + codeine)
- Mouthwash with a solution of 0.12% Chlorhexidine
- cone beam computed tomography CBCT
- 4 months postoperatively: CBCT
Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique
- Conditions
- Bone Regeneration
- Being tested
- bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone regenerationProcedure or surgery
bone regeneration using bio-oss collagen
| Study group | Role | What they receive |
|---|---|---|
| Bio-oss Collagen | Experimental | 90% xengeneic bovine bone partciles + 10% collagen type I Receives: Procedure: bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations
cbct radiographic measurements
Measured: 1 year
Secondary outcomes (1)
linear measurements of the amount of grafted bone resorption
cbct radiographic measurements
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start1 Jan 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338139
- Sponsor's protocol ID
- USJ-2019-112
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: article publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration: a Human Study
- ClinicalTrials.gov ID
- NCT04338139
- Acronym / sponsor ID
- USJ-2019-112
- Conditions
- Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 8 Apr 2020 (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.
to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study:
- Pre-operatively:
- cone beam computed tomography CBCT
- 1 minute mouthwash with a 0.12% Chlorhexidine solution
- Full thickness muco-periosteal flap and ridge curettage.
- Drilling and implant placement (any implant system)
- Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane.
- Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material.
- Post-operatively:
- Medication:
- Amoxicilline (1g) or Clindamycine (300mg)
- Analgesic, (paracetamol + codeine)
- Mouthwash with a solution of 0.12% Chlorhexidine
- cone beam computed tomography CBCT
- 4 months postoperatively: CBCT
Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bio-oss Collagen | Experimental | Procedure: bone regeneration90% xengeneic bovine bone partciles + 10% collagen type I |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age >18 years old
- Smoking <10 cigarettes/day (Light smoker)
- Good general health.
- Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding.
Key exclusion criteria (4 listed)
- A pregnant or nursing mother
- Pathologies that may impair bone healing: diabetes, autoimmune diseases, corticosteroids, chemotherapy.
- Orthodontic treatment in progress or planned
- Adjacent risk teeth
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 |
|---|---|---|
| bone regenerationbone regeneration using bio-oss collagen | Procedure or surgery | Bio-oss Collagen |
Primary outcome
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations
Time frame: 1 year
cbct radiographic measurements
1 secondary outcome
linear measurements of the amount of grafted bone resorption
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: Yes. article publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone regeneration in people with Bone Regeneration, run by Saint-Joseph University at 1 site in Lebanon.
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: status not confirmed, as of the sponsor's last update on 10 Apr 2020. 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 Lebanon. 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?
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?
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations (time frame: 1 year). 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 10 Apr 2020.