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OpenTrials
Completed

NCT Number: NCT06645925

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Dental Continuing Education

Cairo, Cairo Governorate, 11347, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

One Step Protocol

Procedure

FGG will be done simultaneous with implant placement

Two Steps Protocol

Procedure

Conventional FGG protocol, prior to implant placement

Primary outcomes

  1. Keratinized tissue width

    Time frame: 12 months

    Optical scans using intraoral scanner (Runyes® Model V5) were obtained at baseline, 3, 6 and 12 months post-operative for each patient. All the optical scans in standard tessellation language (STL) format, were imported to the digital software (Exocad). The best-fit algorithm was used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. KTW (mm) was measured from the preoperative MGJ to the new MGJ using distance measurement tool in the software. KTW measurements were taken at mesial, mid-buccal and distal sites on the buccal side of the implant, values at the three sites were then averaged. Difference between KTW baseline and KTW follow-up was then analyzed to present the changes in KTW

Secondary outcomes

  1. Bucco-lingual width bone changes

    Time frame: 12 Months

    Postoperative CBCT evaluation was performed to all the recruited patients after 1 year to assess bucco-lingual (BL) bone width changes at three levels; at implant platform, 2mm and 5mm below the implant platform. To perform radiographic measurements and comparisons and to ensure standardization and reproducibility of the CBCT images, superimposition of DICOM file sets of each patient were done using Fusion module software (OnDemand3D ver, 1.0.9, Cybermed), which allowed sub-voxel accuracy. On the fusion module, both initial and postoperative volumes were superimposed and loaded at the same time. To measure the bucco-lingual (BL) bone width changes, the lingual surface of the implant was used as a reference point. A reference line was constructed along the lingual surface of the implant on the cross-sectional cut of the postoperative CBCT volume. Then, both baseline and postoperative CBCT volumes we

  2. Survival Rate

    Time frame: 12 Months

    Implant survival criteria were chosen according to Albrektsson et al. (1986). Surgical and prosthetic complications were also evaluated throughout the follow up timeline.

  3. Total volume Changes

    Time frame: 12 months

    Total volume change (mm3) was calculated at 3 and 12 months postoperative via surface volume analysis within the AOI for each patient. The best-fit algorithm (iterative closet point algorithm) was used to superimpose digital surface models, when comparing each AOI throughout out the follow up periods. To measure the volume gain, the solid preoperative scans were subtracted from the follow-up scans using the Boolean operations software tool. This step will produce a new virtual object representing the volume gained. A three-dimensional (3D) inspection and metrology software (Geomagic Control X, 2022.1.0) was used to calculate the volume gain in mm3 using the measure volume tool.

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Collaborators

  • International Dental Contiuing Education

Registry information

Official study title

Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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