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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04813081
Enrollment
32
Registered
2021-03-24
Start date
2017-05-01
Completion date
2019-03-04
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Reported Outcome

Keywords

quality of life, graft

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.

Interventions

PROCEDUREFree 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.

Sponsors

Kutahya Health Sciences University
CollaboratorOTHER
Istanbul Aydın University
CollaboratorOTHER
University of Beykent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up timesBaseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.

Secondary

MeasureTime frameDescription
Agebaseline18-65 years

Other

MeasureTime frameDescription
Graft volume (GV)during surgerygraft vertical height X graft mesiodistal length X graft thickness
Surgery localizationbaselinemaxilla, mandible, anterior, posterior
Operation timeduring surgeryoperation time between of first incision and last suture
Genderbaselinemale, female
Visual Analog Scale (VAS)postoperative 1., 2., 3., 4., 5., 6. and 7. daysa 100-mm horizontal scale and classify the level of postoperative pain experience from 0 (no pain) to 100 (the worst pain ever experienced)
Painkiller consumptionpostoperative 1., 2., 3., 4., 5., 6. and 7. daysthe total number of painkillers for each follow-up day
Satisfaction questionnairesfirst monthA questionnaire designed by authors with 12 questions was used to assess patient satisfaction. Answers were either categorized as positive or negative.
Keratinized gingival width (KGW)baseline, first monththe distance between the gingival margin and mucogingival junction from tooth/implant in operation area

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026