Clinician- vs. Patient-Reported Esthetic Outcomes After Coronally Advanced Flap

November 3, 2026 updated by: Ezgi Gürbüz, Kutahya Health Sciences University

Comparison of Clinician- and Patient-Reported Esthetic Outcomes Following Coronally Advanced Flap Procedures for the Treatment of Gingival Recession

This study aims to evaluate the relationship between clinician-assessed esthetic outcomes, measured using the Root Coverage Esthetic Score, and patient-reported esthetic outcomes, recorded on a Visual Analog Scale, at 6 months following the treatment of Cairo Recession Type 1 and Type 2 gingival recessions with a coronally advanced flap, combined with a connective tissue graft where clinically indicated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this prospective clinical study, patients who apply to our clinic due to the esthetic complaint or dentin sensitivity will be included. After initial periodontal treatment, patients who meet the criteria will have a coronally positioned flap applied under local anesthesia. In areas where the keratinized tissue width is 2 mm or more and the keratinized tissue thickness is more than 1 mm, a coronally positioned flap will be applied alone. In areas where the keratinized tissue width is less than 2 mm and/or the keratinized tissue thickness is 1 mm or less, a connective tissue graft will be applied in addition to the coronally positioned flap. Clinician and patient results will be compared in the esthetic evaluations to be performed six months after the surgical procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy individuals
  • Individuals over 18 years of age
  • Individuals who do not smoke and/or consume alcohol
  • Individuals without active periodontitis
  • Individuals with full-mouth plaque and bleeding scores of less than 15%
  • Presence of single or multiple gingival recessions in the maxilla or mandible
  • The affected tooth must be single-rooted
  • Presence of Cairo classification Type 1 or Type 2 gingival recession on the buccal surface of the tooth
  • A recession depth of at least 2 mm

Exclusion Criteria:

  • Individuals with uncontrolled systemic diseases
  • Women who are pregnant or breastfeeding
  • Individuals who smoke and/or consume alcohol
  • Individuals with active periodontitis
  • Cases involving tooth rotation or malposition
  • Individuals currently undergoing orthodontic treatment
  • Gingival recessions associated with teeth that have undergone endodontic treatment or require restorations
  • Teeth with dental caries
  • Gingival recessions with non-carious cervical lesions that have a horizontal depth (step depth) greater than 1 mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coronally advanced flap procedure

Coronally advanced flap procedure for Cairo type 1 or 2 gingival recession sites
Procedure: Coronally advanced flap with or without connective tissue graft

Patients will have a coronally positioned flap applied under local anesthesia. In areas where the keratinized tissue width is 2 mm or more and the keratinized tissue thickness is more than 1 mm, a coronally positioned flap will be applied alone. In areas where the keratinized tissue width is less than 2 mm and/or the keratinized tissue thickness is 1 mm or less, a connective tissue graft will be applied in addition to the coronally positioned flap.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Root Coverage Esthetic Score
Time Frame: Post-operative 6th month

The Root Coverage Esthetic Score evaluates five variables 6 months following surgery (gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color).
Post-operative 6th month
Patient-reported esthetic outcome
Time Frame: Post-operative 6th month

Patient-reported esthetic outcome will be measured by the Visual Analog Scale (0 representing the minimum value, and 100 maximum value).
Post-operative 6th month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recession depth
Time Frame: Pre-operative and post-operative 6th month

The distance between gingival margin and cemento-enamel junction
Pre-operative and post-operative 6th month
Keratinized tissue width
Time Frame: Pre-operative and post-operative 6th month

The distance between gingival margin and mucogingival junction
Pre-operative and post-operative 6th month
Keratinized tissue thickness
Time Frame: Pre-operative and post-operative 6th month

The thickness measured 1.5 mm apical to the gingival margin
Pre-operative and post-operative 6th month
Vestibular depth
Time Frame: Pre-operative and post-operative 6th month

The distance between the gingival margin and the greatest concavity at the mucosal fold
Pre-operative and post-operative 6th month
Mean root coverage
Time Frame: Post-operative 6th month

([Pre-operative Recession Depth - Post-operative Recession Depth] / Pre-operative Recession Depth) × 100
Post-operative 6th month
Linear dimension change
Time Frame: Post-operative 6th month

The changes in the horizontal plane measured by superimposition of the STL files
Post-operative 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSBU002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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