Clinical trial NCT03334994: Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using CTG Around Immediate Dental Implants vs Immediate Dental Implants Alone in the Esthetic Zone.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Dental Implants Connective Tissue Graft Esthetic Zone
Keywords: Immediate dental implant, Connective tissue graft, Esthetic zone.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Facial gingival level
timeFrame: Up to 6 months
Secondary outcomes:
measure: Pain score
timeFrame: Up to 12 days
measure: Patient satisfaction
timeFrame: Up to 6 month
measure: Tissue biotype
timeFrame: Up to 6 months
measure: Pink esthetic score
timeFrame: Up to 6 months
measure: Width of keratinized mucosa
timeFrame: Up to 6 months
measure: Bleeding on probing
timeFrame: Up to 6 months
measure: Probing depth
timeFrame: Up to 6 months
measure: Probing attachment level
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University, Faculty of Dentistry.
Study officials:
References: