Analysis of Root Coverage Stability.

February 1, 2024 updated by: CARLO BERTOLDI, Azienda Ospedaliero-Universitaria di Modena

Very Long-term Analysis of Root Coverage Stability Using Subepithelial Connective Tissue Graft Techniques for Gingival Recession Treatment.

One-hundred and one healthy participants (221 gingival recessions-GRs) were treated from 1987 to 1996. The probing depth (PD), keratinized tissue width (KTW), gingival recession depth (RD), gingival recession width (RW), gingival recession area (RA) were evaluated and considered at baseline and along time. The obtained data will be evaluated and compared.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Dental-periodontal procedures and clinical measurements.

Dental and periodontal conditions were assessed and treated according to needs in all participants. Emergencies, such as pain or acute dental-periodontal infections, were treated to establish a stable dental-periodontal condition. Cause-related therapy, including patient motivation and professional oral hygiene, was planned and completed.

At the end of cause-related therapy, the following baseline clinical measurements were taken by an investigator: probing depth (PD), keratinized tissue width (KTW), full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), bleeding on probing (BoP), gingival recession depth (RD), gingival recession width (RW), and gingival recession area (RA).

PD and KTW were evaluated using a periodontal probe (University of North Carolina Probe 15 tip) to the nearest 0.5mm. PD was measured at 4 aspects per tooth axially, from the free gingival margin to the most apical part of the sulcus, and, additionally, PD at the mid buccal point; KTW at the mid-buccal point, from the free gingival margin to the mucogingival-junction (MGJ). FMPS was recorded as the percentage of total tooth surfaces (4 aspects per tooth) displaying the presence of plaque, FMBS was calculated as the percentage of total tooth surfaces (4 aspects per tooth) showing bleeding on probing (BoP) was dichotomously assessed.

The bi-dimensional shape of each exposed root surface was reproduced with a lead sheet template. The template had the shape of a triangle with a curved base lining the cemento-enamel-junction (CEJ) and two sides lining the mesial and distal margins of the GR merging at the most apical point of the GR. All templates were measured, coded and stored. The following measurements were recently repeated using an image analysis software: RD, from the most apical point of the triangle to the base; RW, measured at the CEJ level (i.e., at the base of the template) and RA, as the total template area.

These measurements were performed from baseline (before surgery).

Surgery.

All surgical procedures were performed by the same trained operator under local anesthesia.

The recipient site started with an intrasulcular incision on the buccal aspect of the involved teeth. The incision was mesio-distally extended to dissect the buccal aspect of the adjacent papillae. Two oblique releasing incisions were performed from the mesial and distal sides of the horizontal incisions beyond MGJ. A full thickness trapezoid flap, next the dental roots, was raised. Partial dissection was made next the papillae and, apically, at the interproximal places.

After the initial preparation of the recipient site and flap, the bilaminar technique required the withdrawal of palatal connective graft. At the palatal donor site, a horizontal incision was made about 3 mm apical to the free gingival margin. For the epithelial connective tissue graft (ECTG), a second incision was made undermining and splitting the palatal flap. Vertical incisions were carried out mesially and distally joining them to the horizontal incision and performing the palatal flap. Another horizontal incision was made apically on the connective tissue to sever the graft tissue. The graft tissue, 1-1.5 mm thick, was placed in the recipient site to cover the exposed dental roots as far as the CEJ, enlarging mesially and distally on the preserved connective and periosteum of the interproximal sites. Absorbable interrupted and compressive subperiosteal sutures were performed to give stability to the graft. Then, if need to ensure flap mobilization and passivity, a partial thickness dissection was made beyond the MGJ, leaving the underlying periosteum in place and release also the muscle tension, allowing the passive mobilization of the flap that had to cover completely the connective tissue graft (CTG) and the dental roots over the CEJ at least of 2mm. The partial thickness dissection was performed immediately before the graft positioning and suture to avoid flap suffering. The pedicle flap was sutured without residual tension. Each of these surgical techniques could be advantageously used both in cases of single or multiple gingival recessions (GRs).

After surgery, patients were instructed to discontinue toothbrushing of the treated area for 7-10 days. Patients were reinforced to use the roll technique, by soft-bristle toothbrushing outside the treated area during the first month after surgery. Interdental brushes and dental floss in the treated area were forbidden for 1-month. Flap sutures were removed after 7-10 days, and therefore the same toothbrushing prescriptions performed after surgery for outside areas were introduced also in the treated areas. Chlorhexidine rinses were prescribed twice a day for 1 min. About 1-month after surgery, all patients were instructed to resume mechanical tooth cleaning. Patients were recalled for professional supportive care in accordance with Italian health rules and regulations on public dentistry (Essential·Level·of·Assistance - LEA), Law no.·419-30·November·1998, regulating the public dentistry) every 6-24 months whenever possible, and ever in case of need. Patients were recalled for clinical re-evaluations.

Study Type

Observational

Enrollment (Actual)

101

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

  • Italy
      • Modena, Italy, 41124
        • Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of the Modena University Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants screened for the presence of at least one tooth presenting with gingival recession requiring subepithelial tissue graft (bilaminar technique), examined and treated from 1987 at the Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of Modena University Hospital.

Description

Inclusion Criteria:

Absence of relevant medical conditions: Medical history of good health. Good oral hygiene: full-mouth plaque score (FMPS) ≤20%. Low level of residual infection: full-mouth bleeding score (FMBS) ≤20%. Participants showing good levels of compliance were selected. Presence of at least one tooth presenting with gingival recession (GR) requiring subepithelial tissue graft, and with identifiable cement-enamel junction (CEJ).

GR exhibiting an identifiable cemento-enamel junction, and absence of plaque or bleeding on probing (BoP) in the sites scheduled for the procedure.

GR defects Miller Class I or II without furcation involvement.

Exclusion Criteria:

Pregnant or lactating. Smokers and participants with history of alcohol abuse. Periodontal disease.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Langer & Langer technique
Participants undergoing Langer & Langer surgical technique
Procedure: Gingival recession regenerative surgery
Bilaminar technique was performed by the same trained operator, opening a primary flap in correspondence of the recession site. Tissue was harvested from palatal donor site and grafted beneath the primary flap
Nelson' modified technique
Participants undergoing Nelson' modified surgical technique
Procedure: Gingival recession regenerative surgery
Bilaminar technique was performed by the same trained operator, opening a primary flap in correspondence of the recession site. Tissue was harvested from palatal donor site and grafted beneath the primary flap
Coronally advanced flap and subepithelial graft
Participants undergoing Coronally advanced flap and subepithelial graft surgical technique
Procedure: Gingival recession regenerative surgery
Bilaminar technique was performed by the same trained operator, opening a primary flap in correspondence of the recession site. Tissue was harvested from palatal donor site and grafted beneath the primary flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal pocket probing depth (PD)
Time Frame: From surgery to December 2023
Measurements of the periodontal pocket depth in millimeters
From surgery to December 2023
Keratinized tissue width (KTW)
Time Frame: From surgery to December 2023
Measurements of the width of keratinized tissue (gingiva), in millimeters, from the free gingival margin to the mucogingival junction
From surgery to December 2023
Gingival recession depth (RD)
Time Frame: From surgery to December 2023
Measurements of the depth of the gingival recession, in millimeters, from the cementoenamel junction to the most apical part of the gingival recession
From surgery to December 2023
Gingival recession width (RW)
Time Frame: From surgery to December 2023
Measurements of the width of the gingival recession, in millimeters, from the mesial to distal part of the uncovered cementoenamel junction
From surgery to December 2023
Gingival recession area (RA)
Time Frame: From surgery to December 2023
Measurements of the area, in square millimeters, of the gingival recession
From surgery to December 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between initial and late measurements of probing depth (PD)
Time Frame: From surgery to December 2023
Evaluation of mutual correlation of probing depth (PD) with all the measured indices listed as primary outcome
From surgery to December 2023
Correlation between initial and late measurements of keratinized tissue width (KTW)
Time Frame: From surgery to December 2023
Evaluation of mutual correlation of keratinized tissue width (KTW) with all the measured indices listed as primary outcome
From surgery to December 2023
Correlation between initial and late measurements of gingival recession depth (RD)
Time Frame: From surgery to December 2023
Evaluation of mutual correlation of gingival recession depth (RD) with all the measured indices listed as primary outcome
From surgery to December 2023
Correlation between initial and late measurements of gingival recession width (RW)
Time Frame: From surgery to December 2023
Evaluation of mutual correlation of gingival recession width (RW) with all the measured indices listed as primary outcome
From surgery to December 2023
Correlation between initial and late measurements of gingival recession area (RA)
Time Frame: From surgery to December 2023
Evaluation of mutual correlation of gingival recession area (RA) with all the measured indices listed as primary outcome
From surgery to December 2023

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Collaborators

University of Modena and Reggio Emilia
The European Research Group on Periodontology (ERGOPerio)
University of Firenze and Siena, Napoli, Italy

Investigators

  • Principal Investigator: Carlo Bertoldi, MD DDS, University of Modena and Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 1987

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB008723

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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