Skip to main content
OpenTrials
Completed

NCT Number: NCT06238427

Soft Tissue Augmentation Around Dental Implant

Patients were randomly distributed into two groups (G1 and G2), all patients were treated by a submerged dental implant protocol and free gingival graft (FGG) harvested from the palate as follows:

* Group 1 (G1), received the FGG two months before implant placement. * Group 2 (G2), received the FGG at the time of second-stage surgery (i.e. at the time of healing abutment placement).

All periodontal and radiographic assessments were done by the same operator who was neither involved in the evaluation nor the distribution process. The operator did all the evaluation steps and was completely blinded to the treatment protocol.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingival Atrophy Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wafaa saleh

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

In this investigation, a randomized clinical trial was employed. The patient's randomization was completed by one of the department's senior residents, who was not involved in the trial and was unaware of any relevant treatment plan. A computer-generated randomization list used a randomization table to perform the randomization (SPSS v23.0). Patients were randomly distributed into two groups (G1 and G2), all patients were treated by a submerged dental implant protocol and FGG harvested from the palate. All patients received a thorough description of all procedures involved in the study. Signing a written consent was mandatory for being enrolled in the study. Complete medical and dental histories were recorded for all patients and complete clinical intraoral and extraoral examinations were done for all patients.

Selected patients were questioned about the cause and time of extractions, whether extractions were because of periodontal disease, dental decay or other causes. Previous experiences with dental procedures were also discussed. Intraoral photographs were taken to record the existing condition of teeth and mucosa before implant placement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 21 years or older
  • Systemic Condition: Healthy
  • Keratinized Mucosa Width: Less than 2mm at the intended implant site
  • Bucco-lingual Bone Width: At least 5.5 mm in a single edentulous space
  • Mesio-distal Distance: At least 7 mm between adjacent teeth in a single edentulous space
  • Minimal Bone Height: Not less than 10 mm
  • Residual Alveolar Ridge: Healthy and well-formed, covered with firm mucosa
  • Periodontal Health: Absence of signs of periodontal bone loss or significant soft tissue .loss in teeth adjacent to the implant site
  • Inter-arch Space: Adequate, exceeding 7 mm

Exclusion criteria

  • Cooperation: Uncooperative patients
  • Pregnancy: Individuals with known pregnancies
  • Parafunctional Habits: Abnormal parafunctional habits such as bruxism and clenching
  • Systemic Illnesses: Patients with systemic illnesses that could disrupt healing
  • Medication: Individuals receiving systemic corticosteroids or other drugs impacting .osseointegration or post-operative healing
  • Smoking: Smokers consuming more than 10 cigarettes per day

Treatment and study plan

Primary outcomes

  1. Keratinized Mucosa Width (KMW)

    Time frame: Baseline, 1 month, 3 months, 6 months, and 9 months

    Measurement Method: The assessment of KMW involved measuring from the alveolar ridge zenith to the muco-gingival junction (MGJ) using a calibrated periodontal probe.

    Unit of Measure: Millimeters (mm)

  2. Soft Tissue Thickness (STT)

    Time frame: Baseline, 1 month, 3 months, 6 months, and 9 months

    Measurement Method: STT was determined 1.5 mm apical to the soft tissue margin (STM) using a short anesthesia needle or endodontic micro-opener with a silicon stopper.

    Unit of Measure: Millimeters (mm) Measurement Procedure: The needle was inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was felt. The silicon stopper was placed in tight contact with the soft tissue surface, and the penetrated part was measured on an endodontic ruler. Measurements were rounded to the nearest half of a millimeter.

  3. Graft Shrinkage

    Time frame: 1 month, 3 months, 6 months, and 9 months

    The decrease in the size of the graft at each follow-up time was compared to the baseline. size. It was presented in percentage

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Impact of Timing of Soft Tissue Augmentation to Increase Width of Keratinized Mucosa Around Dental Implant

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.