PES After Soft Tissue Augmentation Using CTG Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone

NCT03425864 | Completed

• 1 other identifier: 2010
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to compare the esthetic result and stability of gingival tissue over the immediate implant only and immediate implant with connective tissue in patients with single non-restorable tooth in the esthetic zone. The main null hypothesis to be tested is that the addition of SCTG to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.

Conditions

Soft Tissue Augmentation

Keywords

immediate implant; connective tissue graft

Outcome Measures

Primary Outcomes (1)

• pink esthetic score

  evaluation of pink esthetic score around immediate implant only in esthetic zone around immediate implant with connective tissue graft in esthetic zone

  should be measured after 8 months below implant and graft placement

Secondary Outcomes (2)

• tissue piotype

  should be measured after 6 months below implant and graft placement

• width of keratinized gingiva

  should be measured after 6 months below implant and graft placement

Study Arms (2)

immediate implant

OTHER

patient will receive immediate implant alone.

Device: immediate implant

immediate implant with connective tissue graft

ACTIVE COMPARATOR

patient will receive immediate implant and connective tissue gaft

Procedure: connective tissue graft; Device: immediate implant

Interventions

connective tissue graft PROCEDURE

patient will receive immediate implant and connective tissue graft

Also known as: subepithelial connective tissue graft

immediate implant with connective tissue graft

immediate implant DEVICE

patient will receive immediate implant with connective tissue graft.

Also known as: post extraction dental implant

immediate implant; immediate implant with connective tissue graft

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-restorable teeth located within the maxillary anterior area and premolars. Age ranged between 20 to 50 years old. Sufficient vertical inter-arch space upon centric occlusion. Patients with good oral hygiene. Intact labial/buccal bone plate.
• \. Age: 20-50. 2. Patients with single non-restorable teeth in anterior or premolar area. 3. "Patients with adequate bone volume for the dental implant procedure". 5. Patients who are compliant to oral hygiene measures. 6. Patient consent approval and signing.

You may not qualify if:

• Patients with any systemic disease that could affect normal healing of tissue and predictable outcome.
• Patients with any habits that might affect osseointegration, such as heavy smoking and alcoholism.
• Pregnant women.
• Patients with untreated periodontal disease or the presence of pathologic condition at implant site.
• Patients with Parafunctional habits that produce overload on the implant such as bruxism and clenching.
• Shallow palate.

Sponsors & Collaborators

• Nada Farouk Hasan Abd El-Aziz: lead
• Cairo University: collaborator

Study Sites (1)

Nada Abd El Aziz

Minya, Minya Governorate, 6666666666, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded Blinding will be done to the clinical, radiographic assessors, without involving them in sequence generation or allocation concealment or surgery performing. Blinding of the biostatistian.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Specialist

Model Details: Eligible patients will be randomized using sequence generation program (Random.org in equal proportions between control group (immediate implant alone) and study group (immediate implant covered with sub-epithelial connective tissue graft with full coverage technique).

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 8, 2018
• Study Start: July 11, 2017
• Primary Completion: September 13, 2020
• Study Completion: October 13, 2020
• Last Updated: June 18, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)