Soft Tissue Thickness Arround Implants
Conditions
Keywords
collagen matrix, dental implant, subepithelial connective tissue graft, soft tissue augmentation
Brief 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 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.
Interventions
PROCEDUREdental implant
we placed our implants and simultaneously grafted either fibroguide or CTG and after 3 months we did the second stage surgery
PROCEDUREFibrogide membrane
we were comparing the efficacy of Fibrogide with the Connective tissue graft
PROCEDUREconnective tissue graft
the control group was the connective tissue graft group and the test group was the Fibrogide group
PROCEDUREsecond stage
second stage to determine the thickness gained after the graft and to place a healing abutment
Sponsors
Saint-Joseph University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Previous and concurrent medication affecting bone and mucosal healing. * Disease affecting bone and connective tissue metabolism. * Immediate implant placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| keratinized tissue height | 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 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| time of the surgery | during the surgery |
Countries
Lebanon
Outcome results
None listed