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

Study Overview
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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.

Official Title
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Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in the Esthetic Zone. Randomized Controlled Trial.

Conditions
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Immediate Dental Implants Connective Tissue Graft Esthetic Zone

Intervention / Treatment
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* Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-55 Patients with single or multiple non-restorable teeth in maxillary anterior or premolar area. Patients with adequate bone volume for the dental implant procedure. Patients who are compliant to oral hygiene measures. Patient consent approval and signing. Exclusion Criteria: Heavy smokers. Systemic disease that contraindicates implant placement or surgical procedures. No or poor patient's compliance. Psychological problems. Pathology at the site of intervention. Pregnancy females.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group: immediate implant alone<br>Patient will be treated with immediate implant alone. | Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.<br>* Patients will be treated with connective tissue graft combined with immediate implant.<br>|
| Active Comparator: (Group A) immediate implant alone<br>Patient will be treated with immediate implant alone. | Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.<br>* Patients will be treated with connective tissue graft combined with immediate implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial gingival level | FGL was evaluated by measuring the distance between the level of soft tissues and the lower border of the customized template that was used as a reference line at three readings mesially, mid-facially and distally. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Visual analog scale was recorded every day for 12 days follow-up and the patient marks on the line the point they feel that it represents their response | Up to 12 days | 
| Patient satisfaction | Post-Surgical Patient Satisfaction Questionnaire (PSPSQ). The patient questionnaire evaluates patients' perception and subjective admiration of the final result of the treatment | Up to 6 month | 
| Tissue biotype | Thickness of the peri-implant mucosa around the implant | Up to 6 months | 
| Pink esthetic score | seven different variables: mesial papilla, distal papilla, facial soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture at the facial aspect of the implant site | Up to 6 months | 
| Width of keratinized mucosa | distance from the mucogingival junction (MGJ) to the gingival margin | Up to 6 months | 
| Bleeding on probing | Bleeding was provoked by sweeping the peri-implant mucosal sulcus using a periodontal probe. | Up to 6 months | 
| Probing depth | distance from the peri- implant mucosal margin to the bottom of the peri-implant sulcus | Up to 6 months | 
| Probing attachment level | distance from the base of the peri-implant sulcus to the implant shoulder using periodontal probe at four sites | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immediate dental implant, Connective tissue graft, Esthetic zone.