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Completed

NCT Number: NCT05386667

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

In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University Faculty of Dentistry Department of Periodontology

Denizli, 20070, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Majezik %0.25 oral spray

Drug

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

Aftamed oral spray

Other

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

Crystalin oral spray

Other

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

Free gingival graft harvesting

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Color match

    Time frame: 21 days

    scoring the color match of the healed tissue area with the patient's remaining tissue

  3. 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.

  4. 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

  5. complete epithelization

    Time frame: 21 days

    Examination of epithelialization with 3% oxygenated water. keeping records according to the foaming rate in the tissue

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 23, 2022
Registry last updated
May 23, 2022

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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