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

Not Applicable

Completed

• Conditions: Immediate Dental Implants Connective Tissue Graft Esthetic Zone

• Registration Number: NCT03334994
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Study Start: 2018-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-02
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Facial gingival level	Up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Pain score	Up to 12 days	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
Pink esthetic score	Up to 6 months	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
Probing attachment level	Up to 6 months	distance from the base of the peri-implant sulcus to the implant shoulder using periodontal probe at four sites
Width of keratinized mucosa	Up to 6 months	distance from the mucogingival junction (MGJ) to the gingival margin
Patient satisfaction	Up to 6 month	Post-Surgical Patient Satisfaction Questionnaire (PSPSQ). The patient questionnaire evaluates patients' perception and subjective admiration of the final result of the treatment
Tissue biotype	Up to 6 months	Thickness of the peri-implant mucosa around the implant
Bleeding on probing	Up to 6 months	Bleeding was provoked by sweeping the peri-implant mucosal sulcus using a periodontal probe.
Probing depth	Up to 6 months	distance from the peri- implant mucosal margin to the bottom of the peri-implant sulcus

Trial Locations

Locations (1)

Cairo University, Faculty of Dentistry.; 🇪🇬 Giza, Egypt