Clinical trial NCT06585813: Implants Placement with Simultaneous Soft Tissue Augmentation Using a Collagen Matrix Compared to Connective Tissue Graft: a Pilot 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Soft Tissue Thickness Arround Implants
Keywords: collagen matrix
dental implant
subepithelial connective tissue graft
soft tissue augmentation
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Adults ;18 years old.
* Patients with adequate oral hygiene (FMPI\&amp;amp;lt;20% and FMBI\&amp;amp;lt;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 (\&amp;amp;gt;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.

Primary outcomes:
measure: keratinized tissue height
timeFrame: at the day of the surgery and after 3 months
measure: mucosal thickness
timeFrame: at the day of the surgery and after 3 months
Secondary outcomes:
measure: time of the surgery
timeFrame: during the surgery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint-Joseph University
Study officials:
affiliation: Saint-Joseph University /American University of Baghdad
name: Nada Naaman, DDS,Msc in periodontology,PHD
role: STUDY_DIRECTOR
References: