Implants Placement with Simultaneous Soft Tissue Augmentation Using a Collagen Matrix Compared to Connective Tissue Graft: a Pilot Study

NCT06585813 | Completed Phase 4 DMC

• 1 other identifier: USJ -2023-62
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Thickness Arround Implants

Keywords

collagen matrix; dental implant; subepithelial connective tissue graft; soft tissue augmentation

Outcome Measures

Primary Outcomes (2)

• keratinized tissue height

  we will calculate the keratinized tissue height before the 1st surgery and before the 2nd stage with a periodontal probe

  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.

  at the day of the surgery and after 3 months

Secondary Outcomes (1)

• time of the surgery

  during the surgery

Study Arms (2)

Fibrogide group

EXPERIMENTAL

we are comparing the grafting of fibrogide(VCMX) with the connective tissue graft on multiple implant placement

Procedure: dental implant; Procedure: Fibrogide membrane; Procedure: second stage

Connective Tissue graft Group

EXPERIMENTAL

Procedure: dental implant; Procedure: connective tissue graft; Procedure: second stage

Interventions

dental implant PROCEDURE

we placed our implants and simultaneously grafted either fibroguide or CTG and after 3 months we did the second stage surgery

Connective Tissue graft Group; Fibrogide group

Fibrogide membrane PROCEDURE

we were comparing the efficacy of Fibrogide with the Connective tissue graft

Fibrogide group

connective tissue graft PROCEDURE

the control group was the connective tissue graft group and the test group was the Fibrogide group

Connective Tissue graft Group

second stage PROCEDURE

second stage to determine the thickness gained after the graft and to place a healing abutment

Connective Tissue graft Group; Fibrogide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Joseph University

Beirut, Beyrouth, Lebanon

Location

MeSH Terms

Interventions

Dental Implants; Labor Stage, Second

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Labor Onset; Labor, Obstetric; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Nada Naaman, DDS,Msc in periodontology,PHD

  Saint-Joseph University /American University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2022
• Primary Completion: April 29, 2024
• Study Completion: June 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

LE (1)