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Completed

NCT Number: NCT04813081

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

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).

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Key information

Conditions

Patient Reported Outcome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beykent University Faculty of Dentistry

Istanbul, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free gingival graft

Procedure

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.

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

    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 outcomes

  1. Age

    Time frame: baseline

    18-65 years

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Beykent

Other

Collaborators

  • Istanbul Aydın University
  • Kutahya Health Sciences University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2021
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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