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

Immediate Dental Implants Connective Tissue Graft Esthetic Zone Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334994
• Other study ID #: 302017
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: February 2, 2020

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Dental Implants Connective Tissue Graft Esthetic Zone

Intervention

Procedure:
• Intervention group:(Group B) connective tissue graft combined with immediate implant.
Patients will be treated with connective tissue graft combined with immediate implant.

Locations

Country	Name	City	State
Egypt	Cairo University, Faculty of Dentistry.	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Tissue biotype	Thickness of the peri-implant mucosa around the implant	Up to 6 months
Secondary	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
Secondary	Width of keratinized mucosa	distance from the mucogingival junction (MGJ) to the gingival margin	Up to 6 months
Secondary	Bleeding on probing	Bleeding was provoked by sweeping the peri-implant mucosal sulcus using a periodontal probe.	Up to 6 months
Secondary	Probing depth	distance from the peri- implant mucosal margin to the bottom of the peri-implant sulcus	Up to 6 months
Secondary	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