The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life
23. mars 2021 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Istanbul, Tyrkia, 34500
- Beykent University Faculty of Dentistry
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Free gingival graft around dental implant patients
Test Group (TG) consists of patients have free gingival graft around dental implant patients
|
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.
|
|
Aktiv komparator: Free gingival graft around the teeth
Control Group (CG) consists of patients have free gingival graft around the teeth.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Age
Tidsramme: baseline
|
18-65 years
|
baseline
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gender
Tidsramme: baseline
|
male, female
|
baseline
|
|
Keratinized gingival width (KGW)
Tidsramme: baseline, first month
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: berceste güler, phd, Kutahya Health Sciences University
- Studieleder: serap karakış akcan, phd, Beykent University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2017
Primær fullføring (Faktiske)
31. januar 2019
Studiet fullført (Faktiske)
4. mars 2019
Datoer for studieregistrering
Først innsendt
18. mars 2021
Først innsendt som oppfylte QC-kriteriene
23. mars 2021
Først lagt ut (Faktiske)
24. mars 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- B.30.2.AYD.0.00.00-480.2/184
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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