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

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ClinicalTrials.gov Identifier: NCT04813081
Recruitment Status : Completed
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Collaborators:
Kutahya Health Sciences University
Istanbul Aydın University
Information provided by (Responsible Party):
Serap Karakış Akcan, University of Beykent

Study Description
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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
Patient Reported Outcome Procedure: Free Gingival Graft Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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.
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 : January 31, 2019
Actual Study Completion Date : March 4, 2019
Arms and Interventions
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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
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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 [ Time Frame: 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 [ Time Frame: baseline ]
    18-65 years


Other Outcome Measures:
  1. Gender [ Time Frame: baseline ]
    male, female

  2. Keratinized gingival width (KGW) [ Time Frame: baseline, first month ]
    the distance between the gingival margin and mucogingival junction from tooth/implant in operation area

  3. Graft volume (GV) [ Time Frame: during surgery ]
    graft vertical height X graft mesiodistal length X graft thickness

  4. Surgery localization [ Time Frame: baseline ]
    maxilla, mandible, anterior, posterior

  5. Operation time [ Time Frame: during surgery ]
    operation time between of first incision and last suture

  6. Satisfaction questionnaires [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: postoperative 1., 2., 3., 4., 5., 6. and 7. days ]
    the total number of painkillers for each follow-up day


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813081


Locations
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Turkey
Beykent University Faculty of Dentistry
Istanbul, Turkey, 34500
Sponsors and Collaborators
University of Beykent
Kutahya Health Sciences University
Istanbul Aydın University
Investigators
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Study Director: serap karakış akcan, phd Beykent University
Principal Investigator: berceste güler, phd Kutahya Health Sciences University
More Information
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Publications of Results:

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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: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Serap Karakış Akcan, University of Beykent:
quality of life
graft