Clinical trial NCT04813081: The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life
Official title: The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Reported Outcome
Keywords: quality of life
graft
Lead sponsor: University of Beykent
Sponsor class: OTHER
Collaborators: name: Kutahya Health Sciences University
name: Istanbul Aydın University
First posted: 2021-03-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were defined as two study groups: Test Group (TG) consists of patients have free gingival graft around dental implant patients and Control Group (CG) consists of patients have free gingival graft around the teeth.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.
Secondary outcomes:
measure: Age
timeFrame: baseline
Other outcomes:
measure: Gender
timeFrame: baseline
measure: Keratinized gingival width (KGW)
timeFrame: baseline, first month
measure: Graft volume (GV)
timeFrame: during surgery
measure: Surgery localization
timeFrame: baseline
measure: Operation time
timeFrame: during surgery
measure: Satisfaction questionnaires
timeFrame: first month
measure: Visual Analog Scale (VAS)
timeFrame: postoperative 1., 2., 3., 4., 5., 6. and 7. days
measure: Painkiller consumption
timeFrame: postoperative 1., 2., 3., 4., 5., 6. and 7. days
Locations:
city: Istanbul
country: Turkey
facility: Beykent University Faculty of Dentistry
Study officials:
affiliation: Beykent University
name: serap karakış akcan, phd
role: STUDY_DIRECTOR
affiliation: Kutahya Health Sciences University
name: berceste güler, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.