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OpenTrials
Completed

NCT Number: NCT06585813

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

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Key information

Conditions

Soft Tissue Thickness Arround Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint-Joseph University

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dental implant

Procedure

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

Fibrogide membrane

Procedure

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

connective tissue graft

Procedure

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

second stage

Procedure

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. time of the surgery

    Time frame: during the surgery

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.