Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.

August 9, 2022 updated by: Gencay Keceli, Hacettepe University

Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?

In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
50

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 Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

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 to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single tooth recession more than 2mm
  • Gingival thickness less than 1mm

Exclusion Criteria:

  • unstable endodontic conditions or presence of any restoration/abrasion,
  • tooth mobility, any surgical history or gingival enlargement in the area,
  • smoking
  • uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Active Comparator: Intraoral
In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.
Procedure: Intraorally de-epithelialization
In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.
Active Comparator: Extraoral
In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.
Procedure: Extraorally de-epithelialization
In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

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
Recession reduction
Time Frame: 3rd month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
3rd month
Recession reduction
Time Frame: 6th month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
6th month
Recession reduction
Time Frame: 12th month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
12th 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 width (RW)
Time Frame: 6th month
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
6th month
Probing pocket depth (PD)
Time Frame: 6th month
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
6th month
Clinical attachment level (CAL)
Time Frame: Baseline
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
Baseline
Clinical attachment level (CAL)
Time Frame: 6th month
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
6th month
Clinical attachment level (CAL)
Time Frame: 12th month
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
12th month
Keratinized tissue change (KTC)
Time Frame: 6th month
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
6th month
Keratinized tissue change (KTC)
Time Frame: 12th month
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
12th month
amount of deciduous cells
Time Frame: at the day of the surgery.
Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.
at the day of the surgery.
percentage of deciduous cells
Time Frame: at the day of the surgery
amount of deciduous cells Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.
at the day of the surgery
Recession Depth (RD)
Time Frame: Baseline.
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Baseline.
Recession Depth (RD)
Time Frame: 3rd month
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
3rd month
Recession Depth (RD)
Time Frame: 6th month
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
6th month
Recession Depth (RD)
Time Frame: 12th month
RD, was measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
12th month
Keratinized Tissue Height (KTH)
Time Frame: baseline
TH, was measured from gingival margin to the mucogingival junction (MGJ).
baseline
Keratinized Tissue Height (KTH)
Time Frame: 3rd month
TH, was measured from gingival margin to the mucogingival junction (MGJ).
3rd month
Keratinized Tissue Height (KTH)
Time Frame: 6th month
TH, was measured from gingival margin to the mucogingival junction (MGJ).
6th month
Keratinized Tissue Height (KTH)
Time Frame: 12th month
TH, was measured from gingival margin to the mucogingival junction (MGJ).
12th month
Gingival Thickness (GT)
Time Frame: baseline
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
baseline
Gingival Thickness (GT)
Time Frame: 3rd month
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
3rd month
Gingival Thickness (GT)
Time Frame: 6th month
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
6th month
Gingival Thickness (GT)
Time Frame: 12th month
GT, was measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
12th month
Recession width (RW)
Time Frame: baseline
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
baseline
Recession width (RW)
Time Frame: 3rd month
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
3rd month
Recession width (RW)
Time Frame: 12th month
Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.
12th month
Probing pocket depth (PD)
Time Frame: baseline
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
baseline
Probing pocket depth (PD)
Time Frame: 3rd month
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
3rd month
Probing pocket depth (PD)
Time Frame: 12th month
Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.
12th month
Clinical attachment level (CAL)
Time Frame: 3rd month
Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.
3rd month
Keratinized tissue change (KTC)
Time Frame: 3rd month
Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.
3rd month
Wound healing index (WHI)
Time Frame: 3rd month
Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
3rd month
Wound healing index (WHI)
Time Frame: 6th month
Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
6th month
Wound healing index (WHI)
Time Frame: 12th month
Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.
12th month
Tissue appearance (TA)
Time Frame: 3rd month
Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
3rd month
Tissue appearance (TA)
Time Frame: 6th month
Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
6th month
Tissue appearance (TA)
Time Frame: 12th month
Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.
12th month
Dentine hypersensitivity (DH)
Time Frame: 3rd month
Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
3rd month
Dentine hypersensitivity (DH)
Time Frame: 6th month
Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
6th month
Dentine hypersensitivity (DH)
Time Frame: 12th month
Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).
12th month
Aesthetics (A)
Time Frame: 3rd month
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
3rd month
Aesthetics (A)
Time Frame: 6th month
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
6th month
Aesthetics (A)
Time Frame: 12th month
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
12th month
Vestibuler Depth
Time Frame: baseline
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
baseline
Vestibuler Depth
Time Frame: 3rd month
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
3rd month
Vestibuler Depth
Time Frame: 6th month
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
6th month
Vestibuler Depth
Time Frame: 12th month
VD was measured from the gingival margin to the deepest point of to vestibule sulcus.
12th 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.
Hacettepe 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 (Actual)

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.
July 4, 2021

Primary Completion (Actual)

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.
July 30, 2022

Study Completion (Actual)

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.
August 5, 2022

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).
August 7, 2022

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.
August 7, 2022

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.
August 9, 2022

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.
August 11, 2022

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.
August 9, 2022

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.
August 1, 2022

More Information

Terms related to this study

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.
  • quality of graft

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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