- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04706078
Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique
8 gennaio 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
55
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Sichuan
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Chengdu, Sichuan, Cina, 610041
- West China Hospital of Stomatology
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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)
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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)
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The biotype of gingival was also determined by periodontal probe.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
papilla height
Lasso di tempo: Between June 2018 and June 2020.
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Presence/absence of papilla height was assessed visually
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Between June 2018 and June 2020.
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Modified Plaque Index (mPI)
Lasso di tempo: Between June 2018 and June 2020.
|
plaque accumulation around the marginal peri-implant tissue was assessed
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Between June 2018 and June 2020.
|
Modified Sulcus Bleeding Index
Lasso di tempo: Between June 2018 and June 2020.
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the bleeding tendency of the marginal peri-implant tissue was evaluated
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Between June 2018 and June 2020.
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Probing Depth (PD, in millimeters)
Lasso di tempo: 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
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Between June 2018 and June 2020.
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Gingival margin level
Lasso di tempo: Between June 2018 and June 2020.
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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
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Between June 2018 and June 2020.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
first bone-implant contact (fBIC) and implant shoulder (IS)
Lasso di tempo: 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.
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Between June 2018 and June 2020.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- [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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 giugno 2018
Completamento primario (Effettivo)
1 giugno 2020
Completamento dello studio (Effettivo)
1 giugno 2020
Date di iscrizione allo studio
Primo inviato
5 gennaio 2021
Primo inviato che soddisfa i criteri di controllo qualità
8 gennaio 2021
Primo Inserito (Effettivo)
12 gennaio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 gennaio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 gennaio 2021
Ultimo verificato
1 gennaio 2021
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2009033
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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