Soft Tissue Augmentation Around Dental Implant

NCT ID: NCT06238427

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-13
• Study Completion Date: 2020-06-15

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.

Conditions

Gingival Atrophy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Group 1 participants underwent free gingival graft placement two months before implant placement.

No interventions assigned to this group

Group2

Group 2 in which the participants underwent the placement of the free gingival graft during the second stage of surgery, specifically at the time of healing abutment placement

No interventions assigned to this group

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samah Elmeadawy, Ph.D

Role: STUDY_DIRECTOR

Mansoura University

Locations

Wafaa saleh

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

A11100221

Identifier Type: -

Identifier Source: org_study_id