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

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.

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.

Study Overview

• Status: Completed
• Conditions: Immediate Dental Implants Connective Tissue Graft Esthetic Zone
• Intervention / Treatment: Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Cairo University, Faculty of Dentistry.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group: immediate implant alone; Patient will be treated with immediate implant alone.	Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.; Patients will be treated with connective tissue graft combined with immediate implant.
ACTIVE_COMPARATOR: (Group A) immediate implant alone; Patient will be treated with immediate implant alone.	Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.; Patients will be treated with connective tissue graft combined with immediate implant.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): February 2, 2020

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (ACTUAL): November 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Immediate dental implant, Connective tissue graft, Esthetic zone.
• Other Study ID Numbers: 302017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No