Clinical trial NCT06238427: Soft Tissue Augmentation Around Dental Implant
Official title: Impact of Timing of Soft Tissue Augmentation to Increase Width of Keratinized Mucosa Around Dental Implant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingival Atrophy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty patients (12 female / 8 male) seeking dental implant placement due to missing teeth and deficient keratinized mucosa width were enrolled in this observational study. The study population was selected from patients attending the clinic of the Periodontology Department of Oral Medicine and Periodontology at Mansoura University. Recruitment occurred from July 2019 to June 2022..

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Keratinized Mucosa Width (KMW)
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Soft Tissue Thickness (STT)
timeFrame: Baseline, 1 month, 3 months, 6 months, and 9 months
measure: Graft Shrinkage
timeFrame: 1 month, 3 months, 6 months, and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Wafaa saleh
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Samah Elmeadawy, Ph.D
role: STUDY_DIRECTOR
References: