Implants Placement with Simultaneous Soft Tissue Augmentation Using a Collagen Matrix Compared to Connective Tissue Graft: a Pilot Study
NCT ID: NCT06585813
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
4 participants
INTERVENTIONAL
2022-10-10
2024-06-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Fibrogide group
we are comparing the grafting of fibrogide(VCMX) with the connective tissue graft on multiple implant placement
dental implant
we placed our implants and simultaneously grafted either fibroguide or CTG and after 3 months we did the second stage surgery
Fibrogide membrane
we were comparing the efficacy of Fibrogide with the Connective tissue graft
second stage
second stage to determine the thickness gained after the graft and to place a healing abutment
Connective Tissue graft Group
dental implant
we placed our implants and simultaneously grafted either fibroguide or CTG and after 3 months we did the second stage surgery
connective tissue graft
the control group was the connective tissue graft group and the test group was the Fibrogide group
second stage
second stage to determine the thickness gained after the graft and to place a healing abutment
Interventions
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dental implant
we placed our implants and simultaneously grafted either fibroguide or CTG and after 3 months we did the second stage surgery
Fibrogide membrane
we were comparing the efficacy of Fibrogide with the Connective tissue graft
connective tissue graft
the control group was the connective tissue graft group and the test group was the Fibrogide group
second stage
second stage to determine the thickness gained after the graft and to place a healing abutment
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Previous and concurrent medication affecting bone and mucosal healing.
* Disease affecting bone and connective tissue metabolism.
* Immediate implant placement.
18 Years
ALL
Yes
Sponsors
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Saint-Joseph University
OTHER
Responsible Party
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Principal Investigators
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Nada Naaman, DDS,Msc in periodontology,PHD
Role: STUDY_DIRECTOR
Saint-Joseph University /American University of Baghdad
Locations
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Saint-Joseph University
Beirut, Beyrouth, Lebanon
Countries
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Other Identifiers
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USJ -2023-62
Identifier Type: -
Identifier Source: org_study_id
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