Pain, PostoperativeNCT05386667
Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.
An observational study of Pain, Postoperative and Healing Wound, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Healing Wound, Hemorrhage
- What is being tested?
- Majezik %0.25 oral spray, Aftamed oral spray and Crystalin oral spray
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2019to 15 Mar 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study consists of all patients, who were planned to be applied free gingival graft for mucogingival surgery
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 10Show fewer
- Smoking
- Excessive gag reflex
- Operations are carried out with conscious sedation.
- Patients who do not want to sign consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry Department of Periodontology
Denizli, 20070
About this study
In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG).
Read the 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
- Conditions
- Pain, Postoperative, Healing Wound, Hemorrhage, Analgesia
- Being tested
- Majezik %0.25 oral spray, Aftamed oral spray, Crystalin oral spray, Free gingival graft harvesting
- Medical subject headings
- Pain, Postoperative, Hemorrhage, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Majezik %0.25 oral sprayDrug
Also called Free gingival graft harvesting
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.
Aftamed oral sprayOther
Also called Free gingival graft harvesting
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.
Crystalin oral sprayOther
Also called Free gingival graft harvesting
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.
Free gingival graft harvestingProcedure or surgery
Free gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients were not given anything after FGG. Receives: Procedure: Free gingival graft harvesting | |
| Flurbiprofen | Oral spray containing 0.075 g flurbiprofen administered after FGG Receives: Drug: Majezik %0.25 oral spray; Procedure: Free gingival graft harvesting | |
| Hypochlorous acid | Oral spray containing hypochlorous acid applied after FGG Receives: Other: Crystalin oral spray; Procedure: 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 Receives: Other: Aftamed oral spray; Procedure: Free gingival graft harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (5)
Visual Analogue Scale
Recording the pain perception of the patients on a scale from 0 to 10. 0 - no pain 10 - worst pain
Measured: 21 days
Color match
scoring the color match of the healed tissue area with the patient's remaining tissue
Measured: 21 days
delayed bleeding
examining the patient whether there is postoperative bleeding, if there is a positive, if not, it should be recorded as negative.
Measured: 21 days
burning sensation
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
Measured: 21 days
complete epithelization
Examination of epithelialization with 3% oxygenated water. keeping records according to the foaming rate in the tissue
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start5 Mar 2019
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSAN LEKTEMUR ALPAN, Pamukkale University
- Investigators
- AYSAN LEKTEMUR ALPAN, PhD, Principal investigator, Pamukkale Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386667
- Sponsor's protocol ID
- 05.03.2019/05
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may share the obtained data personally, but the decision of this is not yet clear.
Publications
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.
PubMed 30007054Hassan 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.
PubMed 34426739Yildirim 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.
PubMed 28914592
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.
- ClinicalTrials.gov ID
- NCT05386667
- Acronym / sponsor ID
- 05.03.2019/05
- Conditions
- Pain, Postoperative, Healing Wound, Hemorrhage, Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (FGG).
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: Free gingival graft harvestingPatients were not given anything after FGG. |
| Flurbiprofen | – | Drug: Majezik %0.25 oral spray, Procedure: Free gingival graft harvestingOral spray containing 0.075 g flurbiprofen administered after FGG |
| Hypochlorous acid | – | Other: Crystalin oral spray, Procedure: Free gingival graft harvestingOral spray containing hypochlorous acid applied after FGG |
| Hyaluronic acid | – | Other: Aftamed oral spray, Procedure: Free gingival graft harvestingAn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consists of all patients, who were planned to be applied free gingival graft for mucogingival surgery
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Majezik %0.25 oral sprayAlso: Free gingival graft harvestingFree 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. | Drug | Flurbiprofen |
| Aftamed oral sprayAlso: Free gingival graft harvestingFree 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 | Hyaluronic acid |
| Crystalin oral sprayAlso: Free gingival graft harvestingFree 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 | Hypochlorous acid |
| Free gingival graft harvestingFree gingival graft was taken from the palatal mucosa of the patients in order to increase the attached gingiva. | Procedure or surgery | Control, Flurbiprofen, Hyaluronic acid, Hypochlorous acid |
Primary outcome
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.
5 secondary outcomes
Visual Analogue Scale
Time frame: 21 days
Color match
Time frame: 21 days
delayed bleeding
Time frame: 21 days
burning sensation
Time frame: 21 days
complete epithelization
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 30007054Isler 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.
- Background: PubMed 34426739Hassan 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.
- Background: PubMed 28914592Yildirim 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.
- Individual participant dataSharing planned: Undecided. We may share the obtained data personally, but the decision of this is not yet clear.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYSAN LEKTEMUR ALPAN, PhD principal investigator
Pamukkale Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Healing Wound, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Landry's Wound Healing Index (WHI) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386667, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.