- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04219436
L'effet de l'utilisation de deux techniques de suture différentes sur la stabilité marginale gingivale libre
L'effet de l'utilisation de deux techniques de suture différentes sur la stabilité marginale gingivale libre après un allongement esthétique de la couronne pour le traitement du sourire gingival (essai clinique randomisé)
Gummy smile is one of the major esthetic problems nowadays; it is due to several causes that either dental or skeletal. Etiology of the gummy smile is altered passive eruption, vertical maxillary excess, different gingival enlargement conditions, deficient maxillary lip length and excessive maxillary lip mobility, dento alveolar extrusion, combination of all these factors.
Altered passive eruption is considered to be one of the most major causes, it is classified into two types according to the location of the mucogingival junction with respect to the bone crest and each type has two subtypes . Esthetic crown lengthening is the treatment of choice for subtype B in both types as bone removal is mandatory to create a space for the biological width.
Most of the studies stated that there is some degree of relapse of the gingival tissues after the procedures in the follow ups, that relapse was related to the biotype of the gingival tissues, the flap placement close or far from the bone can be correlated to the suturing technique used for closure of the tissues.
In the investigator's study comparing of two different suturing technique was done to evaluated their effect on gingival tissue relapse, 30 patients (26 females and 4 males) were divided between 2 groups each group consisted of 15 patients. In the first group vertical mattress suturing technique was done in the secondperiosteal vertical suturing technique was.
Evaluation of the tissue relapse was done through the assessment of the amount of the attached gingival tissues level of gingival margin and marginal tissue contour before and after the surgery.
The results of the study showed that tissue relapse was more in the periosteal suturing technique group that was related to the pressure on the tissues due to the fixation of the suture at the periostium, the papillary tissue also showed more inflammation in the follow up period prior to suture removal. The figure of eight group showed less relapse and tissue inflammation as it prevents flap edge overlap and is tension free therefore better blood supply to the tissue.
Patients were generally satisfied post-surgical with their smile, gingival tissue visibility and teeth dimensions inspite of the relapse but it was better than prior to surgery. Also they would recommend it to other patients complaining from the same problem.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Thirty patients (26 females, 4 males), who were candidates for esthetic crown lengthening, participated in this prospective clinical trial.
Group I (15 patients) (vertical mattress suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then External vertical mattress suture was done (periosteal suture).
Group II (15 patients) (periosteal vertical suturing technique) :
Esthetic crown lengthening procedure: internal bevel, sulcular and interdental incisions, flap elevation, bone removal then periosteal vertical suture was done
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Cairo, Egypte
- Faculty of Dentistry Ain Shams University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients complaining from gummy smile (altered passive eruption)
- Bone level is 2 mm or less from the cemento enamel junction
- Teeth included were free from any periodontal destruction
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program
Exclusion Criteria:
- Presence of systemic diseases which could influence the outcome of the therapy (American society of anesthesiologists I, ASA I).
- Patient suffering from periodontitis stage 4 grade c.
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant females and lactating females. .
- Vulnerable groups of patients (handicapped, mentally retarded, prisoners).
- Restored teeth.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: vertical mattress suturing technique
vertical mattress suturing technique is done to close the flap |
vertical mattress suturing technique used for flap closure after esthetic crown lengthening |
|
Comparateur actif: periosteal vertical suturing technique
periosteal vertical suturing technique is done to close the flap |
figure of eight suturing technique used for flap closure after esthetic crown lengthening |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
evaluation of the marginal soft tissue levels rebound
Délai: 6 months
|
determination of soft tissue rebound: is measured as the difference between (the level of free gingival margin after suturing) and (the level of the free gingival margin 6 months post surgical) both measured from fixed reference point on the stent to the free gingival margin |
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Supracrestal gingival tissue
Délai: 6 months
|
the difference between the bone level and the free gingival margin (measured from a fixed reference point on the stent) |
6 months
|
|
Patient satisfaction
Délai: at 6 months post surgical
|
questionnaire (After surgery)
|
at 6 months post surgical
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ahmed gamal, professor, faculty of dentistry ain shams university
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PER16-35M
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
when the study is done the results will be published with the protocol
Délai de partage IPD
the data will be available starting next month and for 1 year
Critères d'accès au partage IPD
the keywords esthetic crown lengthening, suturing techniques in dentistry
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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