Evaluation of Esthetic Outcomes of M-shaped Flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score

Evaluation of Esthetic Outcomes of M-flap Implant Uncovering Technique Versus I-shaped Incision Around Single Implants in the Anterior Maxilla Using Pink Esthetic Score (PES) (RCT)

The aim of this study is to evaluate the soft-tissue profile around a single-tooth implant in the anterior maxilla utilizing the PES after implant uncovering using "M" flap versus I-shaped incision.The primary objective is evaluation of esthetic outcomes around implant using PES.

Hypothesis: The use of I-shaped incision exposure technique will result in better esthetic outcomes.

Study Overview

• Status: Unknown
• Conditions: Dental Implant Failed
• Intervention / Treatment: Procedure: I-incision, M-flap and conventional implant exposure techniques

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with osseointegrated dental implant in the anterior maxilla.
• Patients of 20 - 50 years
• Periodontally healthy patients.
• No intraoral soft and hard tissue pathology.
• No systemic condition that contraindicate surgical intervention.

Exclusion Criteria:

• Intraoral soft and hard tissue pathology.
• Heavy smokers more than 20 cigarettes per day.
• Patients with systemic disease that may affect normal healing.
• Psychiatric problems.
• Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional	Procedure: I-incision, M-flap and conventional implant exposure techniques; Implant uncovering in the second stage using 3 different exposure techniques
Active Comparator: I-incision	Procedure: I-incision, M-flap and conventional implant exposure techniques; Implant uncovering in the second stage using 3 different exposure techniques
Active Comparator: M-flap	Procedure: I-incision, M-flap and conventional implant exposure techniques; Implant uncovering in the second stage using 3 different exposure techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PES	Esthetic outcomes around implant	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): March 15, 2020
• Study Completion (Anticipated): March 30, 2020

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Ezzat Implant Master Thesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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