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Low-intensity Laser Therapy in the Treatment of Gingival Recession (LILT)

17 avril 2014 mis à jour par: Mauro Pedrine Santamaria, UPECLIN HC FM Botucatu Unesp

Connective Tissue Graft Associated or Not With Low Intensity Laser Therapy: A Randomized Clinical Trial

The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at ICT - São José dos Campos, College of Dentistry.

The selected patients were randomly allocated (by a computer generated list) into:

Group CTG (n = 20) - patients who received connective tissue graft to treat gingival recession Group CTG+LILT (n = 20) - patients who received connective tissue graft associated with 8 applications of low-intensity laser therapy to treat gingival recession.

The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. Surgical areas were anesthetized (2% mepivacaine with 1:100,000 epinephrine). Two horizontal incisions were made at right angles to the adjacent interdental papillae, at the level of the CEJ, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap. The exposed root surface was gently scaled and planed to remove any possible irregularities. Afterward, a thin and small connective tissue graft was harvested from the palate using a scalpel with parallel blades (1.0 mm away from each other). The graft was sutured# using single sutures in the papillae, over the root surface, in such a way that covered the CEJ and the recession. Then, the flap was coronally positioned and sutured to completely cover the graft The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed, as depicted in Figure 1. The irradiation was performed with a GaAlAs** diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point)

Clinical parameters were assessed at baseline and 3 and 6 months post-operatively.

Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used (Sigmaplot). The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using VAS were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by QCE analysis, the frequency of complete root coverage, BOP, and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup RES comparisons were performed with a T-test. A significance level of 0.05 was adopted.

Type d'étude

Interventionnel

Inscription (Réel)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • São Paulo
      • São José dos Campos, São Paulo, Brésil, 12243-300
        • UNESP - ICT Odontologia São José dos Campos

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. presenting Miller class I or II gingival recession in the maxillary canines or premolars;
  2. visible cemento-enamel junction (CEJ) in the teeth included in the study and pulp vitality;
  3. patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
  4. patients older than 18 years old;
  5. probing depth ˂ 3 mm in the included teeth; 6) patients who agreed to participate and signed an informed consent form

Exclusion Criteria:

  1. patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
  2. patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
  3. smokers or pregnant women
  4. patients who underwent periodontal surgery in the area of interest; and 5) patients with orthodontic therapy in progress.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur factice: Connective tissue graft (CTG)
The gingival recession defects were treated by connective tissue graft surgical procedure and received the sham application os low-intensity laser therapy.
Technique chirurgicale parodontale pour traiter les récessions gingivales
Expérimental: Connective tissue graft plus laser (CTG+L)
The gingival recession defects were treated by connective tissue graft associated with the application of a LILT protocol
Technique chirurgicale parodontale pour traiter les récessions gingivales

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Percentage of root coverage
Délai: 6 months
6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Esthetic
Délai: 6 months

Two esthetic evaluations were performed: 1 professional and 1 patient-centered. The professional esthetic evaluation was made using the photographs of the baseline and 6 months after surgery set in a before-and-after panel. The professional evaluation was conducted using the root coverage esthetic score (RES).

Esthetic outcomes were also evaluated from the patient's point of view. Using a hand mirror, the patients viewed the gingival recession before and after 6 months and were asked to rate the esthetics of the tooth included in the study on a VAS scale.

6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Stephanie B Fernandes-Dias, DDS, Ms, UPECLIN HC FM Botucatu Unesp
  • Chaise d'étude: Maria Aparecida N Jardini, PhD, UPECLIN HC FM Botucatu Unesp

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2011

Achèvement primaire (Réel)

1 décembre 2013

Achèvement de l'étude (Réel)

1 janvier 2014

Dates d'inscription aux études

Première soumission

16 avril 2014

Première soumission répondant aux critères de contrôle qualité

17 avril 2014

Première publication (Estimation)

21 avril 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

21 avril 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 avril 2014

Dernière vérification

1 avril 2014

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 0978412.5.0000.0077

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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