Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.

May 18, 2022 updated by: AYSAN LEKTEMUR ALPAN, Pamukkale University
In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting. The effectiveness of these 3 different commercially available agents containing flurbiprofen, hyaluronic acid, and hypochlorous acid, after use 2., 4.7. and on the 14th day, wound healing and pain perception was compared with the control group. primary observation was obtained by visual analog scale, wound healing index, bleeding of tissue, color match, and amount of painkiller used by the patient were also recorded

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20070
        • Pamukkale University Faculty of Dentistry Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population of the study consists of all patients, who were planned to be applied free gingival graft for mucogingival surgery

Description

Inclusion Criteria:- Patients with systematic conditions are classified as The American Society of Anesthesiologists Class I

-

Exclusion Criteria:

  • Pregnancy, lactation, and taking contraceptive pills.
  • Oversensitivity or anaphylactic reactions which contraindicate the intervention.
  • Orofacial neurological symptoms.
  • Infections at operation zone.
  • Psychotropic medicine, sedative, or non-steroid anti-inflammatory drugs use which can alter the sense of pain.
  • Pathological mental conditions (dementia, psychosis) and lack of cooperation.
  • Smoking
  • Excessive gag reflex
  • Operations are carried out with conscious sedation.
  • Patients who do not want to sign consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Patients were not given anything after FGG.
Procedure: Free gingival graft harvesting
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.
Flurbiprofen
Oral spray containing 0.075 g flurbiprofen administered after FGG
Procedure: Free gingival graft harvesting
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.
Drug: Majezik %0.25 oral spray

Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.

After FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.

Other Names:
  • Free gingival graft harvesting
Hypochlorous acid
Oral spray containing hypochlorous acid applied after FGG
Procedure: Free gingival graft harvesting
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.
Other: Crystalin oral spray

Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.

After FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.

Other Names:
  • Free gingival graft harvesting
Hyaluronic acid
An oral spray containing the main component of the product is hyaluronic acid (sodium salt) with a high molecular weight of 30 mg / 100 g was given to patients after FGG
Procedure: Free gingival graft harvesting
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.
Other: Aftamed oral spray

Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.

After FGG, the patients were asked to apply this spray to the palatal mucosa 3 times a day.

Other Names:
  • Free gingival graft harvesting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Landry's Wound Healing Index (WHI)
Time Frame: 21 days
WHI was performed on the basis of postoperative healing characteristics categorized as tissue color, response to palpation, incision margins, and suppuration.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 21 days
Recording the pain perception of the patients on a scale from 0 to 10. 0 - no pain 10 - worst pain
21 days
Color match
Time Frame: 21 days
scoring the color match of the healed tissue area with the patient's remaining tissue
21 days
delayed bleeding
Time Frame: 21 days
examining the patient whether there is postoperative bleeding, if there is a positive, if not, it should be recorded as negative.
21 days
burning sensation
Time Frame: 21 days
Evaluation of the burning sensation felt in the healing area of the patient's palate from 0 to 10. 0-no burning sensation 10- excessive burning
21 days
complete epithelization
Time Frame: 21 days
Examination of epithelialization with 3% oxygenated water. keeping records according to the foaming rate in the tissue
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: AYSAN LEKTEMUR ALPAN, PhD, Pamukkale Univesity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2019

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05.03.2019/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We may share the obtained data personally, but the decision of this is not yet clear.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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