Wound HealNCT05871190
The Effects Of I-PRF On Gingivectomy and Gingivoplasty
A study testing İnjectable platelet rich fibrin and Gingivectomy anad gingivoplasty in people with Wound Heal, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The study aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) applications on early wound healing after gingivectomy and gingivoplasty surgery. In this randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were performed on 46 patients. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- İnjectable platelet rich fibrin and Gingivectomy anad gingivoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Aug 2021to 20 May 2022
- Phase
- Interventional
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- systemically healthy patients ages 15-40 years, (b) pregnancy or lactation, (c) patients with chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior area, (d) no attachment and bone loss, (e) not using immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs taken or prescribed 2 months before the study attempt, which may affect the study results, wound healing, and coagulation mechanism, and (f) patients with sufficient oral hygiene.
Who cannot join
- patients who had a history of periodontal treatment in the last 6 months, (b) smokers and alcohol users, those who used drugs that may cause gingival enlargement in the last 6 months, (c) patients with poor communication, and (d) patients who did not attend controls at designated times.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences; Ankara, Turkey
Ankara, 06010
About this study
Official title: The Effects Of Injectable Platelet-Rich Fibrin Application On Wound Healing Following Gingivectomy and Gingivoplasty Operations: Single-blind, Randomized Controlled, Prospective Clinical Study
The study aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) applications on early wound healing after gingivectomy and gingivoplasty surgery. In this randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were performed on 46 patients. The postoperative I-PRF-applied surgery areas were compared with control regions. The surgical areas were stained with Mira-2 tone and evaluated in the ImageJ program. Wound healing was evaluated by using the Modified Manchester Scar (MMS) scale and Landry, Turnbull, and Howley (LTH) index. Vascular endothelial growth factor (VEGF) and fibroblast growth factor 10 (FGF-10) concentrations were assessed by enzyme-linked immunoabsorbent assay (ELISA). The seven-day Visual Analog Scale was used to assess pain level.
Considering the results found, I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.
- Conditions
- Wound Heal
- Being tested
- İnjectable platelet rich fibrin, Gingivectomy anad gingivoplasty
- Keywords
- VEGF, FGF-10, I-PRF,gingivectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İnjectable platelet rich fibrinOther
Also called i-prf
I-PRF is a type of platelet-rich fibrin (PRF) product obtained from the patient's own blood. PRF is a kind of tissue regeneration product of blood, rich in platelets, growth factors and cellular components.
Gingivectomy anad gingivoplastyProcedure or surgery
leveling and regulation of the gingiva
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | I-PRF is placed on the wound site after a gingivectomy with the conventional method and closed with a periodontal dressing Receives: Other: İnjectable platelet rich fibrin; Procedure: Gingivectomy anad gingivoplasty |
| control group | Placebo comparator | closure of the wound site with only a periodontal dressing after a gingivectomy with the conventional method. Receives: Procedure: Gingivectomy anad gingivoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of I-PRF on wound healing and epithelialization
I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.
Measured: seven months
Secondary outcomes (1)
effects of biochemical markers on wound healing
In order to see the effects of biochemical markers on wound healing, gingival crevicular fluid samples should be taken at more frequent intervals.
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start23 Aug 2021
- Primary completion15 Mar 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Responsible party
- Principal investigator, Şeyma Çardakçı, Saglik Bilimleri Universitesi
- Investigators
- şeyma ÇARDAKCI BAHAR, Lecturer, Principal investigator, University of Health Sciences; Ankara, TurkeyNebi Cansın KARAKAN, Asst. Prof., Study director, Faculty of Dentistry Afyonkarahisar University of Health Sciences, Afyonkarahisar, TurkeyAyhan VURMAZ, Assoc. Prof., Study chair, Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871190
- Sponsor's protocol ID
- 21.DUS.005
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Injectable Platelet-Rich Fibrin Application On Wound Healing Following Gingivectomy and Gingivoplasty Operations: Single-blind, Randomized Controlled, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05871190
- Acronym / sponsor ID
- 21.DUS.005
- Conditions
- Wound Heal
- Keywords
- VEGF, FGF-10, I-PRF,gingivectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 23 May 2023 (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.
The study aims to evaluate the effects of injectable platelet-rich fibrin (I-PRF) applications on early wound healing after gingivectomy and gingivoplasty surgery. In this randomized controlled single-blind study, gingivectomy and gingivoplasty surgeries were performed on 46 patients. The postoperative I-PRF-applied surgery areas were compared with control regions. The surgical areas were stained with Mira-2 tone and evaluated in the ImageJ program. Wound healing was evaluated by using the Modified Manchester Scar (MMS) scale and Landry, Turnbull, and Howley (LTH) index. Vascular endothelial growth factor (VEGF) and fibroblast growth factor 10 (FGF-10) concentrations were assessed by enzyme-linked immunoabsorbent assay (ELISA). The seven-day Visual Analog Scale was used to assess pain level.
Considering the results found, I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Other: İnjectable platelet rich fibrin, Procedure: Gingivectomy anad gingivoplastyI-PRF is placed on the wound site after a gingivectomy with the conventional method and closed with a periodontal dressing |
| control group | Placebo comparator | Procedure: Gingivectomy anad gingivoplastyclosure of the wound site with only a periodontal dressing after a gingivectomy with the conventional method. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- systemically healthy patients ages 15-40 years, (b) pregnancy or lactation, (c) patients with chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior area, (d) no attachment and bone loss, (e) not using immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs taken or prescribed 2 months before the study attempt, which may affect the study results, wound healing, and coagulation mechanism, and (f) patients with sufficient oral hygiene.
Key exclusion criteria (1 listed)
- patients who had a history of periodontal treatment in the last 6 months, (b) smokers and alcohol users, those who used drugs that may cause gingival enlargement in the last 6 months, (c) patients with poor communication, and (d) patients who did not attend controls at designated times.
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 |
|---|---|---|
| İnjectable platelet rich fibrinAlso: i-prfI-PRF is a type of platelet-rich fibrin (PRF) product obtained from the patient's own blood. PRF is a kind of tissue regeneration product of blood, rich in platelets, growth factors and cellular components. | Other | Test group |
| Gingivectomy anad gingivoplastyleveling and regulation of the gingiva | Procedure or surgery | Test group, control group |
Primary outcome
effects of I-PRF on wound healing and epithelialization
Time frame: seven months
I-PRF applications revealed positive effects on epithelial wound healing after gingivectomy and gingivoplasty operations.
1 secondary outcome
effects of biochemical markers on wound healing
Time frame: seven months
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 2023.
- Individual participant dataSharing planned: Yes
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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.
şeyma ÇARDAKCI BAHAR, Lecturer principal investigator
University of Health Sciences; Ankara, Turkey
Nebi Cansın KARAKAN, Asst. Prof. study director
Faculty of Dentistry Afyonkarahisar University of Health Sciences, Afyonkarahisar, Turkey
Ayhan VURMAZ, Assoc. Prof. study chair
Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İnjectable platelet rich fibrin and Gingivectomy anad gingivoplasty in people with Wound Heal, run by Saglik Bilimleri Universitesi 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 1 inclusion and 1 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 2023. 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. Some participants in this study may receive a placebo. 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?
effects of I-PRF on wound healing and epithelialization (time frame: seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2023.