NCT04102748

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

September 21, 2019

Last Update Submit

September 23, 2019

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

  • PES

    Esthetic outcomes around implant

    3 months

Study Arms (3)

Conventional

ACTIVE COMPARATOR
Procedure: I-incision, M-flap and conventional implant exposure techniques

I-incision

ACTIVE COMPARATOR
Procedure: I-incision, M-flap and conventional implant exposure techniques

M-flap

ACTIVE COMPARATOR
Procedure: I-incision, M-flap and conventional implant exposure techniques

Interventions

I-incision, M-flap and conventional implant exposure techniquesPROCEDURE

Implant uncovering in the second stage using 3 different exposure techniques

ConventionalI-incisionM-flap

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2019

First Posted

September 25, 2019

Study Start

January 1, 2019

Primary Completion

March 15, 2020

Study Completion

March 30, 2020

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

EG(1)