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

Sponsor
University of Beykent (Other)
Overall Status
Completed
CT.gov ID
NCT04813081
Collaborator
Kutahya Health Sciences University (Other), Istanbul Aydın University (Other)
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Free Gingival Graft
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Mar 4, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Free gingival graft around dental implant patients

Test Group (TG) consists of patients have free gingival graft around dental implant patients

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.

Active Comparator: Free gingival graft around the teeth

Control Group (CG) consists of patients have free gingival graft around the teeth.

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.

Outcome Measures

Primary Outcome Measures

  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 [Baseline, 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 Outcome Measures

  1. Age [baseline]

    18-65 years

Other Outcome Measures

  1. Gender [baseline]

    male, female

  2. Keratinized gingival width (KGW) [baseline, first month]

    the distance between the gingival margin and mucogingival junction from tooth/implant in operation area

  3. Graft volume (GV) [during surgery]

    graft vertical height X graft mesiodistal length X graft thickness

  4. Surgery localization [baseline]

    maxilla, mandible, anterior, posterior

  5. Operation time [during surgery]

    operation time between of first incision and last suture

  6. Satisfaction questionnaires [first month]

    A questionnaire designed by authors with 12 questions was used to assess patient satisfaction. Answers were either categorized as "positive" or "negative".

  7. Visual Analog Scale (VAS) [postoperative 1., 2., 3., 4., 5., 6. and 7. days]

    a 100-mm horizontal scale and classify the level of postoperative pain experience from 0 (no pain) to 100 (the worst pain ever experienced)

  8. Painkiller consumption [postoperative 1., 2., 3., 4., 5., 6. and 7. days]

    the total number of painkillers for each follow-up day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beykent University Faculty of Dentistry Istanbul Turkey 34500

Sponsors and Collaborators

  • University of Beykent
  • Kutahya Health Sciences University
  • Istanbul Aydın University

Investigators

  • Study Director: serap karakış akcan, phd, Beykent University
  • Principal Investigator: berceste güler, phd, Kutahya Health Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Serap Karakış Akcan, Assistant professor doctor, University of Beykent
ClinicalTrials.gov Identifier:
NCT04813081
Other Study ID Numbers:
  • B.30.2.AYD.0.00.00-480.2/184
First Posted:
Mar 24, 2021
Last Update Posted:
Mar 24, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serap Karakış Akcan, Assistant professor doctor, University of Beykent

Study Results

No Results Posted as of Mar 24, 2021