- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04706078
Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique
8 janvier 2021 mis à jour par: Wen Luo
Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique to Thick-gingiva and Thin-gingiva Patients Treated With Implant-supported Fixed Prosthesis
To evaluate a cross-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Objective: To evaluate a cross-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis.
Methods and Materials: 55 patients received cross-shaped incision were assigned into thick-gingiva group (29 cases) and thin-gingiva group (26 cases).
Follow-up examination was carried out 3 and 12 months after final restoration.
Clinical and radiographic evaluation including gingival papilla height, modified plaque index, modified sulcus bleeding index, periodontal depth, and crestal marginal bone level were utilized.
Type d'étude
Observationnel
Inscription (Réel)
55
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
-
-
Sichuan
-
Chengdu, Sichuan, Chine, 610041
- West China Hospital of Stomatology
-
-
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
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
The study samples were comprised of patients who had been treated with one bone-level implant (Osstem, Korea) insertion in the first molar region.
Fifty-five subjects were selected from the patients who came to the Department of Oral Implantology, West China Hospital of Stomatology, Sichuan University in China between June 2018 and June 2020.
La description
Inclusion Criteria:
- Good general health, no chronic systemic diseases.
- All subjects included in this study needed to have one missing premolar or molar teeth with adjacent natural teeth.
- All subjects included in the study had been treated with one bone-level implant insertion in the premolar or molar region.
Exclusion Criteria:
- Active periodontal infections.
- Heavy smoking habit (>10 cigarettes per day).
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
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
thick-gingiva group
After insertion of the probe into the facial aspect of the sulcus, the peri-implant biotype can be categorized as thick-gingiva (outline if the probe cannot be seen through the gingival)
|
|
|
thin-gingiva group
After insertion of the probe into the facial aspect of the sulcus, the peri-implant biotype can be categorized as thin-gingiva (outline of the probe can be seen through the gingival)
|
The biotype of gingival was also determined by periodontal probe.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
papilla height
Délai: Between June 2018 and June 2020.
|
Presence/absence of papilla height was assessed visually
|
Between June 2018 and June 2020.
|
|
Modified Plaque Index (mPI)
Délai: Between June 2018 and June 2020.
|
plaque accumulation around the marginal peri-implant tissue was assessed
|
Between June 2018 and June 2020.
|
|
Modified Sulcus Bleeding Index
Délai: Between June 2018 and June 2020.
|
the bleeding tendency of the marginal peri-implant tissue was evaluated
|
Between June 2018 and June 2020.
|
|
Probing Depth (PD, in millimeters)
Délai: Between June 2018 and June 2020.
|
PD was assessed at the mid-buccal, mid-oral, mesial and distal aspects of each implant with a standard periodontal probe, and final value was determined by the average of four aspects
|
Between June 2018 and June 2020.
|
|
Gingival margin level
Délai: Between June 2018 and June 2020.
|
Gingival margin level was assessed by calculating the vertical distance between the most apical point of gingival margin at the buccal aspect of the crown and line connecting the peak of the adjacent mesial and distal natural teeth
|
Between June 2018 and June 2020.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
first bone-implant contact (fBIC) and implant shoulder (IS)
Délai: Between June 2018 and June 2020.
|
the landmarks of first bone-implant contact (fBIC) and implant shoulder (IS) were used for measurements.
fBIC-IS was defined as the vertical distance the first bone-implant contact to implant shoulder, and the distance was assessed at the mesial and distal aspect of implant, respectively.
When the marginal crestal bone was located coronal to the IS, a positive (+) value was given, where a negative (-) value when located apically to the IS, the value was deemed as zero when IS and fBIC coincided.
|
Between June 2018 and June 2020.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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.
Publications générales
- [1] Du H, Gao M, Qi C, Liu S, Lin Y. Drug-induced gingival hyperplasia and scaffolds: they may be valuable for horizontal food impaction. Med Hypotheses 2010;74:984-5. [2] Bidra AS. Nonsurgical management of inflammatory periimplant disease caused by food impaction: a clinical report. J Prosthet Dent 2014;111:96-100. [3] Koori H, Morimoto K, Tsukiyama Y, Koyano K. Statistical analysis of the diachronic loss of interproximal contact between fixed implant prostheses and adjacent teeth. Int J Prosthodont 2010;23:535-40. [4] Gastaldo JF, Cury PR, Sendyk WR. Effect of the vertical and horizontal distances between adjacent implants and between a tooth and an implant on the incidence of interproximal papilla. J Periodontol 2004;75:1242-6. [5] Chow YC, Wang HL. Factors and techniques influencing peri-implant papillae. Implant Dent 2010;19:208-19. [6] Müller HP, Heinecke A, Schaller N, Eger T. Masticatory mucosa in subjects with different periodontal phenotypes. J Clin Periodontol 2000;27:621-6. [7] Yao JW, Wang HL. Assessment of Peri-implant Soft Tissue Adaptive Pressure and Time After Provisional Restorations. Int J Periodontics Restorative Dent 2019;39: 809-15. [8] Salama H, Salama M. The role of orthodontic extrusive remodeling in the enhancement of soft and hard tissue profiles prior to implant placement: a systematic approach to the management of extraction site defects. Int J Periodontics Restorative Dent1993;13,312-33. [9] Man Y, Wang Y, Qu Y, Wang P, Gong P. A palatal roll envelope technique for peri-implant mucosa reconstruction: a prospective case series study. Int J Oral Maxillofac Surg 2013;42:660-5. [10] Agarwal C, Deora S, Abraham D, Gaba R, Kumar BT,Kudva P. Vascularized interpositional periosteal connective tissue flap: A modern approach to augment soft tissue. J Indian Soc Periodontol 2015;19:72-7. [11] Man Y , Wu Q , Wang T , Gong P, Gong T , Qu Y. Split pedicle roll envelope technique around implants and pontics: a prospective case series study. Int J Oral Maxillofac Surg 2015;44:1295-301. [12] Urdaneta RA, Daher S, Lery J, Emanuel K, Chuang SK. Factors associated with crestal bone gain on single-tooth locking-taper implants: the effect of nonsteroidal anti-inflammatory drugs. Int J Oral Maxillofac Implants 2011;26, 1063-78. [13] De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol 2009;36:,428-33. [14] Ronay V, Sahrmann P, Bindl A, Attin T, Schmidlin PR. Current status and perspectives of mucogingival soft tissue measurement methods. J Esthet Restor Dent 2011;23:146-56. [15] Mombelli A, Van Oosten MA, Schurch EJ, Lan NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol 1987;2:145-51. [16] Chang M, Wennström JL, Odman P, Andersson B. Implant supported single-tooth replacements compared to contralateral natural teeth. Crown and soft tissue dimensions. Clin Oral Implants Res 1999;10: 185-94. [17] Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res 2008;19:635-41. [18] Kajiwara N , Masaki C, Mukaibo T,Kondo Y, Nakamoto T, Hosokawa R. Soft tissue biological response to zirconia and metal implant abutments compared with natural tooth: microcirculation monitoring as a novel bioindicator. Implant Dent 2015;24:37-41. [19] Cooper LF, Ellner S, Moriarty J, Felton DA, Paquette D, Molina A, et al. Three-year evaluation of single-tooth implants restored 3 weeks after 1-stage surgery. Int J Oral Maxillofac Implants 2007;22:791-800. [20] Kan JY, Rungcharassaeng K, Liddelow G, Henry P, Goodacre CJ. Periimplant tissue response following immediate provisional restoration of scalloped implants in the esthetic zone: a one-year pilot prospective multicenter study. J Prosthet Dent 2007;97:109-18. [21] Al-Juboori MJ. Interdental Implant Papillae Grow up with Temporary Abutment displaced at Monthly Intervals. J Contemp Dent Pract 2015;16:422-6. [22] Finelle G, Papadimitriou D, Souza A, Katebi N,Gallucci G, Araújo M. Peri-implant soft tissue and marginal bone adaptation on implant with non-matching healing abutments: micro-CT analysis. Clin Oral Implants Res 2015;26:42-6. [23] Farronato D, Santoro G, Canullo L, Botticelli D, Maiorana C, Lang N. Establishment of the epithelial attachment and connective tissue adaptation to implants installed under the concept of
- Luo W, Wang X, Chen Y, Hong Y, Qu Y, Man Y, Wu Y. Radiographic evaluation of a cross-shaped incision technique for thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. BMC Oral Health. 2021 Dec 18;21(1):655. doi: 10.1186/s12903-021-02019-8.
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 (Réel)
1 juin 2018
Achèvement primaire (Réel)
1 juin 2020
Achèvement de l'étude (Réel)
1 juin 2020
Dates d'inscription aux études
Première soumission
5 janvier 2021
Première soumission répondant aux critères de contrôle qualité
8 janvier 2021
Première publication (Réel)
12 janvier 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 janvier 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2009033
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .