Soft Tissue Thickness Arround ImplantsPhase 4NCT06585813
Implants Placement with Simultaneous Soft Tissue Augmentation Using a Collagen Matrix Compared to Connective Tissue Graft: a Pilot Study
A Phase 4 study testing dental implant, Fibrogide membrane and connective tissue graft in people with Soft Tissue Thickness Arround Implants, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
Background: To our knowledge, no study evaluated the use of VCMX at multiple implant sites and compared its efficacy and safety to a SCTG with the same dimensions. Therefore, we propose in the present protocol to evaluate the efficacy of VMCX to increase the thickness and height of soft tissue when placed at the time… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Thickness Arround Implants
- What is being tested?
- dental implant, Fibrogide membrane and connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Oct 2022to 20 Jun 2024
- 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
- Adults ;18 years old.
- Patients with adequate oral hygiene (FMPI\<20% and FMBI\<20%).
- Healed implant sites (tooth extraction at least 8 to 12 weeks before enrolment).
- Patients who need prosthetic rehabilitation of at least two implants in the left and right posterior mandibular area.
- Inadequate amount of soft tissue where the implants are planned to be placed: thin mucosal tissues covering the edentulous alveolar ridge.
- Compliant patients are willing to sign an informed consent.
Who cannot join
- Uncontrolled periodontal disease.
- Heavy smoker (\>10 cigarettes per day).
- General contraindications for dental surgical treatment.
- Insufficient bone volume for implant placement requiring bone augmentation procedures.
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years.
- Pregnancy or breastfeeding.
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- Previous and concurrent medication affecting bone and mucosal healing.
- Disease affecting bone and connective tissue metabolism.
- Immediate implant placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Implant Placement with Simultaneous Soft Tissue Augmentation Using a Volume-stable Collagen Matrix Compared to Autogenous Connective Tissue Graft: a Clinical, Histological and Volumetric Pilot Study
Background: To our knowledge, no study evaluated the use of VCMX at multiple implant sites and compared its efficacy and safety to a SCTG with the same dimensions. Therefore, we propose in the present protocol to evaluate the efficacy of VMCX to increase the thickness and height of soft tissue when placed at the time of multiple implant placement, as compared to SCTG.
Material and Methods: This study will be conducted in the saint joseph university periodontology department on at least 5 to 10 patients. The studied sites are the edentulous posterior mandible in a split-mouth model. The test groups are the groups grafted with VCMX and the control groups are the groups grafted with SCTG.
Some studies have been reported to compare these two techniques. But the specificity of our study is soft tissue augmentation on multiple implant sites in a split-mouth design.
- Conditions
- Soft Tissue Thickness Arround Implants
- Being tested
- dental implant, Fibrogide membrane, connective tissue graft, second stage
- Keywords
- collagen matrix, dental implant, subepithelial connective tissue graft, soft tissue augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantProcedure or surgery
we placed our implants and simultaneously grafted either fibroguide or CTG and after 3 months we did the second stage surgery
Fibrogide membraneProcedure or surgery
we were comparing the efficacy of Fibrogide with the Connective tissue graft
connective tissue graftProcedure or surgery
the control group was the connective tissue graft group and the test group was the Fibrogide group
second stageProcedure or surgery
second stage to determine the thickness gained after the graft and to place a healing abutment
| Study group | Role | What they receive |
|---|---|---|
| Fibrogide group | Experimental | we are comparing the grafting of fibrogide(VCMX) with the connective tissue graft on multiple implant placement Receives: Procedure: dental implant; Procedure: Fibrogide membrane; Procedure: second stage |
| Connective Tissue graft Group | Experimental | Not described Receives: Procedure: dental implant; Procedure: connective tissue graft; Procedure: second stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratinized tissue height
we will calculate the keratinized tissue height before the 1st surgery and before the 2nd stage with a periodontal probe
Measured: at the day of the surgery and after 3 months
mucosal thickness
when doing the1st surgery(implant placement and soft tissue graft) and at the 2nd stage we will perform a mid crestal incision and reflect only the buccal flap , we will then with a periodontal probe calculate the peri-implant soft tissue thickness of the lingual flap (that we did not reflect). finally we will compare both measurments.
Measured: at the day of the surgery and after 3 months
Secondary outcomes (1)
time of the surgery
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Oct 2022
- Primary completion29 Apr 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Thickness Arround ImplantsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nada Naaman, DDS,Msc in periodontology,PHD, Study director, Saint-Joseph University /American University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585813
- Sponsor's protocol ID
- USJ -2023-62
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Implant Placement with Simultaneous Soft Tissue Augmentation Using a Volume-stable Collagen Matrix Compared to Autogenous Connective Tissue Graft: a Clinical, Histological and Volumetric Pilot Study
- ClinicalTrials.gov ID
- NCT06585813
- Acronym / sponsor ID
- USJ -2023-62
- Conditions
- Soft Tissue Thickness Arround Implants
- Keywords
- collagen matrix, dental implant, subepithelial connective tissue graft, soft tissue augmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Background: To our knowledge, no study evaluated the use of VCMX at multiple implant sites and compared its efficacy and safety to a SCTG with the same dimensions. Therefore, we propose in the present protocol to evaluate the efficacy of VMCX to increase the thickness and height of soft tissue when placed at the time of multiple implant placement, as compared to SCTG.
Material and Methods: This study will be conducted in the saint joseph university periodontology department on at least 5 to 10 patients. The studied sites are the edentulous posterior mandible in a split-mouth model. The test groups are the groups grafted with VCMX and the control groups are the groups grafted with SCTG.
Some studies have been reported to compare these two techniques. But the specificity of our study is soft tissue augmentation on multiple implant sites in a split-mouth design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrogide group | Experimental | Procedure: dental implant, Procedure: Fibrogide membrane, Procedure: second stagewe are comparing the grafting of fibrogide(VCMX) with the connective tissue graft on multiple implant placement |
| Connective Tissue graft Group | Experimental | Procedure: dental implant, Procedure: connective tissue graft, Procedure: second stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ;18 years old.
- Patients with adequate oral hygiene (FMPI\<20% and FMBI\<20%).
- Healed implant sites (tooth extraction at least 8 to 12 weeks before enrolment).
- Patients who need prosthetic rehabilitation of at least two implants in the left and right posterior mandibular area.
- Inadequate amount of soft tissue where the implants are planned to be placed: thin mucosal tissues covering the edentulous alveolar ridge.
Key exclusion criteria (9 listed)
- Uncontrolled periodontal disease.
- Heavy smoker (\>10 cigarettes per day).
- General contraindications for dental surgical treatment.
- Insufficient bone volume for implant placement requiring bone augmentation procedures.
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years.
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 |
|---|---|---|
| dental implantwe placed our implants and simultaneously grafted either fibroguide or CTG and after 3 months we did the second stage surgery | Procedure or surgery | Connective Tissue graft Group, Fibrogide group |
| Fibrogide membranewe were comparing the efficacy of Fibrogide with the Connective tissue graft | Procedure or surgery | Fibrogide group |
| connective tissue graftthe control group was the connective tissue graft group and the test group was the Fibrogide group | Procedure or surgery | Connective Tissue graft Group |
| second stagesecond stage to determine the thickness gained after the graft and to place a healing abutment | Procedure or surgery | Connective Tissue graft Group, Fibrogide group |
Primary outcome
keratinized tissue height
Time frame: at the day of the surgery and after 3 months
we will calculate the keratinized tissue height before the 1st surgery and before the 2nd stage with a periodontal probe
mucosal thickness
Time frame: at the day of the surgery and after 3 months
when doing the1st surgery(implant placement and soft tissue graft) and at the 2nd stage we will perform a mid crestal incision and reflect only the buccal flap , we will then with a periodontal probe calculate the peri-implant soft tissue thickness of the lingual flap (that we did not reflect). finally we will compare both measurments.
1 secondary outcome
time of the surgery
Time frame: during the surgery
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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.
Nada Naaman, DDS,Msc in periodontology,PHD study director
Saint-Joseph University /American University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dental implant, Fibrogide membrane and connective tissue graft in people with Soft Tissue Thickness Arround Implants, 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 6 inclusion and 9 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 19 Sep 2024. 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.
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?
keratinized tissue height (time frame: at the day of the surgery and after 3 months). 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 19 Sep 2024.