NCT05386667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

May 18, 2022

Last Update Submit

May 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Landry's Wound Healing Index (WHI)

    WHI was performed on the basis of postoperative healing characteristics categorized as tissue color, response to palpation, incision margins, and suppuration.

    21 days

Secondary Outcomes (5)

  • Visual Analogue Scale

    21 days

  • Color match

    21 days

  • delayed bleeding

    21 days

  • burning sensation

    21 days

  • complete epithelization

    21 days

Study Arms (4)

Control

Patients were not given anything after FGG.

Procedure: Free gingival graft harvesting

Flurbiprofen

Oral spray containing 0.075 g flurbiprofen administered after FGG

Drug: Majezik %0.25 oral sprayProcedure: Free gingival graft harvesting

Hypochlorous acid

Oral spray containing hypochlorous acid applied after FGG

Other: Crystalin oral sprayProcedure: 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

Other: Aftamed oral sprayProcedure: Free gingival graft harvesting

Interventions

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.

Also known as: Free gingival graft harvesting
Flurbiprofen

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.

Also known as: Free gingival graft harvesting
Hyaluronic acid

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.

Also known as: Free gingival graft harvesting
Hypochlorous acid

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

ControlFlurbiprofenHyaluronic acidHypochlorous acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University Faculty of Dentistry Department of Periodontology

Denizli, 20070, Turkey (Türkiye)

Location

Related Publications (3)

  • Isler SC, Eraydin N, Akkale H, Ozdemir B. Oral flurbiprofen spray for mucosal graft harvesting at the palatal area: A randomized placebo-controlled study. J Periodontol. 2018 Oct;89(10):1174-1183. doi: 10.1002/JPER.17-0381. Epub 2018 Aug 29.

    PMID: 30007054BACKGROUND
  • Hassan A, Ahmed E, Ghalwash D, Elarab AE. Clinical Comparison of MEBO and Hyaluronic Acid Gel in the Management of Pain after Free Gingival Graft Harvesting: A Randomized Clinical Trial. Int J Dent. 2021 Aug 14;2021:2548665. doi: 10.1155/2021/2548665. eCollection 2021.

    PMID: 34426739BACKGROUND
  • Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.

    PMID: 28914592BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeHemorrhageAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • AYSAN LEKTEMUR ALPAN, PhD

    Pamukkale Univesity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

March 5, 2019

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations