Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using CTG Around Immediate Dental Implants vs Immediate Dental Implants Alone in the Esthetic Zone.

NCT ID: NCT03334994

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-02-02

Brief Summary

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Aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone.

Detailed Description

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P: Adult patients with single or multiple non-restorable teeth in esthetic zone I: Immediate implant + Connective tissue graft. C: Immediate implant alone. O: Primary Outcome: Facial gingival level Secondary Outcome: Patient satisfaction, probing depth, probing attachment loss, tissue biotype, keratinized mucosal width and bleeding on probing.

P.M will select patients from the outpatient clinic of the Oral Medicine and Periodontology Department - Cairo University. Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.

Conditions

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Immediate Dental Implants Connective Tissue Graft Esthetic Zone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients was randomly classified into two groups:

Group A: Patient will be treated with immediate implant alone. Group B: Patients will be treated with connective tissue graft combined with immediate implant.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Blinded participants: patient will be ensured by masking the instruments during the surgery. The patient will be informed of the steps of the surgery (as mentioned in the consent form) without getting into details. Blinding to the clinical, radiographic assessors is done by not involving them in sequence generation or allocation concealment or surgery performing.

Study Groups

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Control group: immediate implant alone

Patient will be treated with immediate implant alone.

Group Type ACTIVE_COMPARATOR

Intervention group:(Group B) connective tissue graft combined with immediate implant.

Intervention Type PROCEDURE

Patients will be treated with connective tissue graft combined with immediate implant.

(Group A) immediate implant alone

Patient will be treated with immediate implant alone.

Group Type ACTIVE_COMPARATOR

Intervention group:(Group B) connective tissue graft combined with immediate implant.

Intervention Type PROCEDURE

Patients will be treated with connective tissue graft combined with immediate implant.

Interventions

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Intervention group:(Group B) connective tissue graft combined with immediate implant.

Patients will be treated with connective tissue graft combined with immediate implant.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 18-55
2. Patients with single or multiple non-restorable teeth in maxillary anterior or premolar area.
3. Patients with adequate bone volume for the dental implant procedure.
4. Patients who are compliant to oral hygiene measures.
5. Patient consent approval and signing.

Exclusion Criteria

1. Heavy smokers.
2. Systemic disease that contraindicates implant placement or surgical procedures.
3. No or poor patient's compliance.
4. Psychological problems.
5. Pathology at the site of intervention.
6. Pregnancy females.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Parryhan Mohamed Abdelsamie

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University, Faculty of Dentistry.

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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302017

Identifier Type: -

Identifier Source: org_study_id

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