- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04813081
The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life
23. marts 2021 opdateret af: Serap Karakış Akcan, University of Beykent
The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial
The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Thirty-two participants were included who were referred to the periodontology clinic suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or tooth/teeth.
GOHAI-total and GOHAI psychological impact, functional limitation, pain and discomfort, behavioral impact subcategories were recorded at before and postoperative first week and 30th day.
Also, satisfaction questionnaires, number of painkillers and visual analog scale values were recorded.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Kalkun, 34500
- Beykent University Faculty of Dentistry
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Non-smoking
- Teeth and implants with keratinized gingiva width <1 mm
- A healthy periodontal and peri-implant condition
- Patients who didn't have ever experience periodontal surgery had first oral surgery experience with dental FGG operation for the first time
- Patients who underwent implant surgery for the first oral surgery experience
- Maximum two teeth/implants on recipient area
Exclusion Criteria:
- Patients receiving any medication to disrupt wound healing
- Lactation or pregnancy
- Caries or defects on the tooth root surface
- Periapical lesion in the recipient area active periodontal disease
- Patients who have previously had periodontal or oral surgery experiences
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Free gingival graft around dental implant patients
Test Group (TG) consists of patients have free gingival graft around dental implant patients
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In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction.
The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth.
Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.
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Aktiv komparator: Free gingival graft around the teeth
Control Group (CG) consists of patients have free gingival graft around the teeth.
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In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction.
The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth.
Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times
Tidsramme: Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.
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The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.
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Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Age
Tidsramme: baseline
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18-65 years
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baseline
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Gender
Tidsramme: baseline
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male, female
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baseline
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Keratinized gingival width (KGW)
Tidsramme: baseline, first month
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the distance between the gingival margin and mucogingival junction from tooth/implant in operation area
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baseline, first month
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Graft volume (GV)
Tidsramme: during surgery
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graft vertical height X graft mesiodistal length X graft thickness
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during surgery
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Surgery localization
Tidsramme: baseline
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maxilla, mandible, anterior, posterior
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baseline
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Operation time
Tidsramme: during surgery
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operation time between of first incision and last suture
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during surgery
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Satisfaction questionnaires
Tidsramme: first month
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A questionnaire designed by authors with 12 questions was used to assess patient satisfaction.
Answers were either categorized as "positive" or "negative".
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first month
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Visual Analog Scale (VAS)
Tidsramme: postoperative 1., 2., 3., 4., 5., 6. and 7. days
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a 100-mm horizontal scale and classify the level of postoperative pain experience from 0 (no pain) to 100 (the worst pain ever experienced)
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postoperative 1., 2., 3., 4., 5., 6. and 7. days
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Painkiller consumption
Tidsramme: postoperative 1., 2., 3., 4., 5., 6. and 7. days
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the total number of painkillers for each follow-up day
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postoperative 1., 2., 3., 4., 5., 6. and 7. days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: berceste güler, phd, Kütahya Health Sciences University
- Studieleder: serap karakış akcan, phd, Beykent University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.
- McGuire MK, Scheyer ET, Gwaltney C. Commentary: incorporating patient-reported outcomes in periodontal clinical trials. J Periodontol. 2014 Oct;85(10):1313-9. doi: 10.1902/jop.2014.130693. Epub 2014 Jul 18.
- Locker D, Matear D, Stephens M, Lawrence H, Payne B. Comparison of the GOHAI and OHIP-14 as measures of the oral health-related quality of life of the elderly. Community Dent Oral Epidemiol. 2001 Oct;29(5):373-81. doi: 10.1034/j.1600-0528.2001.290507.x.
- Mei CC, Lee FY, Yeh HC. Assessment of pain perception following periodontal and implant surgeries. J Clin Periodontol. 2016 Dec;43(12):1151-1159. doi: 10.1111/jcpe.12618. Epub 2016 Nov 2.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2017
Primær færdiggørelse (Faktiske)
31. januar 2019
Studieafslutning (Faktiske)
4. marts 2019
Datoer for studieregistrering
Først indsendt
18. marts 2021
Først indsendt, der opfyldte QC-kriterier
23. marts 2021
Først opslået (Faktiske)
24. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- B.30.2.AYD.0.00.00-480.2/184
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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