The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life

Patient Reported Outcome Clinical Trial

Official title:

The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813081
• Other study ID #: B.30.2.AYD.0.00.00-480.2/184
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 4, 2019

Study information

• Verified date: March 2021
• Source: University of Beykent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 4, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Reported Outcome

Intervention

Procedure:
• Free Gingival Graft
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.

Locations

Country	Name	City	State
Turkey	Beykent University Faculty of Dentistry	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
University of Beykent	Istanbul Aydin University, Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hämmerle 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, To — View 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. — View 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. Review. — View 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. — View 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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender	male, female	baseline
Other	Keratinized gingival width (KGW)	the distance between the gingival margin and mucogingival junction from tooth/implant in operation area	baseline, first month
Other	Graft volume (GV)	graft vertical height X graft mesiodistal length X graft thickness	during surgery
Other	Surgery localization	maxilla, mandible, anterior, posterior	baseline
Other	Operation time	operation time between of first incision and last suture	during surgery
Other	Satisfaction questionnaires	A questionnaire designed by authors with 12 questions was used to assess patient satisfaction. Answers were either categorized as "positive" or "negative".	first month
Other	Visual Analog Scale (VAS)	a 100-mm horizontal scale and classify the level of postoperative pain experience from 0 (no pain) to 100 (the worst pain ever experienced)	postoperative 1., 2., 3., 4., 5., 6. and 7. days
Other	Painkiller consumption	the total number of painkillers for each follow-up day	postoperative 1., 2., 3., 4., 5., 6. and 7. days
Primary	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	Age	18-65 years	baseline