The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life
1 other identifier
interventional
32
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2019
CompletedFirst Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedMarch 24, 2021
March 1, 2021
1.8 years
March 18, 2021
March 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.
Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.
Secondary Outcomes (1)
Age
baseline
Other Outcomes (8)
Gender
baseline
Keratinized gingival width (KGW)
baseline, first month
Graft volume (GV)
during surgery
- +5 more other outcomes
Study Arms (2)
Free gingival graft around dental implant patients
ACTIVE COMPARATORTest Group (TG) consists of patients have free gingival graft around dental implant patients
Free gingival graft around the teeth
ACTIVE COMPARATORControl Group (CG) consists of patients have free gingival graft around the teeth.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Beykentlead
- Kutahya Health Sciences Universitycollaborator
- Istanbul Aydın Universitycollaborator
Study Sites (1)
Beykent University Faculty of Dentistry
Istanbul, 34500, Turkey (Türkiye)
Related Publications (5)
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.
PMID: 31461778RESULTBerglundh 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.
PMID: 29926491RESULTMcGuire 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.
PMID: 25034790RESULTLocker 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.
PMID: 11553110RESULTMei 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.
PMID: 27554366RESULT
Study Officials
- STUDY DIRECTOR
serap karakış akcan, phd
Beykent University
- PRINCIPAL INVESTIGATOR
berceste güler, phd
Kutahya Health Sciences University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor doctor
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 24, 2021
Study Start
May 1, 2017
Primary Completion
January 31, 2019
Study Completion
March 4, 2019
Last Updated
March 24, 2021
Record last verified: 2021-03