Analysis of Root Coverage Stability.

Sponsor
Azienda Ospedaliero-Universitaria di Modena (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05439382
Collaborator
University of Modena and Reggio Emilia (Other), University of Firenze and Siena, Napoli, Italy (Other), The European Research Group on Periodontology (ERGOPerio) (Other)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gingival recession regenerative surgery

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 Design

Study Type:
Observational
Actual Enrollment :
101 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Very Long-term Analysis of Root Coverage Stability Using Subepithelial Connective Tissue Graft Techniques for Gingival Recession Treatment.
Actual Study Start Date :
Jan 1, 1987
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Periodontal pocket probing depth (PD) [From surgery to December 2023]

    Measurements of the periodontal pocket depth in millimeters

  2. Keratinized tissue width (KTW) [From surgery to December 2023]

    Measurements of the width of keratinized tissue (gingiva), in millimeters, from the free gingival margin to the mucogingival junction

  3. Gingival recession depth (RD) [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

  4. Gingival recession width (RW) [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

  5. Gingival recession area (RA) [From surgery to December 2023]

    Measurements of the area, in square millimeters, of the gingival recession

Secondary Outcome Measures

  1. Correlation between initial and late measurements of probing depth (PD) [From surgery to December 2023]

    Evaluation of mutual correlation of probing depth (PD) with all the measured indices listed as primary outcome

  2. Correlation between initial and late measurements of keratinized tissue width (KTW) [From surgery to December 2023]

    Evaluation of mutual correlation of keratinized tissue width (KTW) with all the measured indices listed as primary outcome

  3. Correlation between initial and late measurements of gingival recession depth (RD) [From surgery to December 2023]

    Evaluation of mutual correlation of gingival recession depth (RD) with all the measured indices listed as primary outcome

  4. Correlation between initial and late measurements of gingival recession width (RW) [From surgery to December 2023]

    Evaluation of mutual correlation of gingival recession width (RW) with all the measured indices listed as primary outcome

  5. Correlation between initial and late measurements of gingival recession area (RA) [From surgery to December 2023]

    Evaluation of mutual correlation of gingival recession area (RA) with all the measured indices listed as primary outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of the Modena University Hospital Modena Italy 41124

Sponsors and Collaborators

  • Azienda Ospedaliero-Universitaria di Modena
  • University of Modena and Reggio Emilia
  • University of Firenze and Siena, Napoli, Italy
  • The European Research Group on Periodontology (ERGOPerio)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
CARLO BERTOLDI, Professor, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier:
NCT05439382
Other Study ID Numbers:
  • RB008723
First Posted:
Jun 30, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CARLO BERTOLDI, Professor, Azienda Ospedaliero-Universitaria di Modena
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022