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Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Posterior Mandibular Implant

M

Misr International University

Status

Enrolling

Conditions

Keratinized Tissue
Free Gingival Graft Volume Change
Free Gingival Graft

Treatments

Procedure: One Step Protocol
Procedure: Two Steps Protocol

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT06645925
IDCE - 13

Details and patient eligibility

About

Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement & simultaneous FGG or the conventional FGG protocol prior to implant placement.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Adults at or above the age of 18.

  • Lower Posterior missing tooth/ teeth with minimal KT < 2mm

  • Sufficient alveolar ridge length minimum 13-15 mm to IAN

    •. Sufficient alveolar ridge width minimum of 6 mm

  • Patients able to tolerate surgical periodontal procedures.

  • Patients who provided an informed consent and accepted the one-year follow-up period.

Exclusion Criteria

  • Patients diagnosed with periodontal diseases (Caton et al., 2018).
  • Current or previous smokers.
  • Pregnant and lactating females.
  • Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
  • Patients with active infection related to the site of implant.
  • Patients with parafunctional habits.
  • Patients with shallow vestibule

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

One Step Protocol
Experimental group
Description:
FGG simultaneous with delayed implant placement
Treatment:
Procedure: One Step Protocol
Two Steps protocol
Active Comparator group
Description:
Conventional FGG protocol, prior to implant placement
Treatment:
Procedure: Two Steps Protocol

Trial contacts and locations

1

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Central trial contact

Nourhan G AbdelAziz, Masters degree periodontology

Data sourced from clinicaltrials.gov

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