Analysis of Root Coverage Stability.

A

Azienda Ospedaliero-Universitaria di Modena

Status

Active, not recruiting

Conditions

Surgery
Gingival Recession
Oral Disease

Treatments

Procedure: Gingival recession regenerative surgery

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT05439382
RB008723

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

101 participants in 3 patient groups

Langer & Langer technique
Description:
Participants undergoing Langer & Langer surgical technique
Treatment:
Procedure: Gingival recession regenerative surgery
Nelson' modified technique
Description:
Participants undergoing Nelson' modified surgical technique
Treatment:
Procedure: Gingival recession regenerative surgery
Coronally advanced flap and subepithelial graft
Description:
Participants undergoing Coronally advanced flap and subepithelial graft surgical technique
Treatment:
Procedure: Gingival recession regenerative surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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