Gingival OvergrowthPRPNCT07124143
The Effect of Platelet-Rich Plasma on Wound Healing After Gingivectomy
A study testing PRP in people with Gingival Overgrowth, run by Duygu Kilic at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the effects of using droplet-form platelet-rich plasma (PRP), known to have positive effects during the intermediate healing process, on wound healing in areas left for secondary healing after gingivectomy. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- PRP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2021to 2 Nov 2024
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals
- Patients with inflammatory gingival overgrowth
- Patients who have not received periodontal treatment in the area to be treated within the last year
- Non-smokers
- Patients with intact periodontal structures
Who cannot join
- Pregnancy or lactation
- Age under 18 or over 55
- Smoking
- Presence of systemic diseases
- Patients who have received periodontal treatment in the area to be treated within the last year
- Use of medications causing gingival overgrowth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry Department of Periodontology
Kayseri, Kayseri, 38000
About this study
Official title: The Effect of Platelet-Rich Plasma on Wound Healing After Gingivectomy: A Randomized Clinical Prospective Study
The aim of the study is to evaluate the effects of using droplet-form platelet-rich plasma (PRP), known to have positive effects during the intermediate healing process, on wound healing in areas left for secondary healing after gingivectomy.
After the gingivectomy procedure, patients will be divided into four groups, each consisting of 10 individuals:
Read more
Group 1 (Control Group): This group will follow the standard post-gingivectomy protocol without any agent applied to the surgical site.
Group 2 (Placebo Group): In this group, the standard protocol will be followed, and physiological saline will be applied to the surgical site in 3-4 drops, four times a day, for 14 days.
Groups 3 and 4 (Study Groups): These groups will follow the standard protocol, with PRP prepared using different kits applied to the surgical site in 3-4 drops, four times a day, for 14 days.
All patients in the groups will be evaluated on the 3rd, 7th, 14th, and 30th days after the gingivectomy procedure. Postoperative pain will be assessed using the Visual Analog Scale (VAS), while wound healing will be evaluated using the Healing Index (Landry et al.) based on photographs of the region. Before taking standardized photographs, the surgical area will be stained with two-tone dye.
Read the detailed description
The aim of this study is to evaluate the effectiveness of platelet-rich plasma (PRP) prepared with different kits in improving the healing rate and enhancing patient comfort during the recovery process in the secondary healing areas following gingivectomy.
Systemically healthy individuals, patients with inflammatory gingival overgrowth, patients without periodontal treatment in the operative area within the last year, non-smokers and patients with intact periodontal structures will be included to the study. Also pregnant or breastfeeding patients, Patients below 18 or above 55 ages, smoking patients, patients with systemic diseases and who received periodontal treatment in the operative area within the last year and who use of medications causing gingival overgrowth will be excluded from the study.
Methodology:
A total of 40 patients meeting the inclusion criteria and willing to participate in the study will be recruited from those attending the Periodontology Clinic at Erciyes University Faculty of Dentistry for gum disease treatment.
Initial Procedures:
All participants will undergo initial periodontal treatment, including scaling and root planing. Periodontal assessments (plaque index, gingival index, probing depth, and attachment loss) will be performed before the initial treatment and at the first month post-treatment.
Study Procedure:
One month after the completion of initial periodontal therapy, gingivectomy will be performed, and the operative sites will be left for secondary healing. Before the procedure, the Pressure Pain Threshold Measurement will be taken for all patients using an algometer.
Participants will be randomly assigned to one of four groups:
Group 1 (Control group): Standard post-gingivectomy protocol without any agent applied to the surgical site.
Group 2 (Placebo): Standard protocol with 3-4 drops of physiological saline applied to the surgical site, four times a day, for 14 days.
Group 3 (PRP Kit 1): Standard protocol with PRP prepared using Kit 1, applied to the surgical site in the same manner as the placebo group.
Group 4 (PRP Kit2): Standard protocol with PRP prepared using Kit 2, applied similarly.
Postoperative Care:
All patients will be prescribed ibuprofen 600 mg (three times daily for three days). Placebo group patients will receive physiological saline in sterile eye drop bottles to apply as instructed.
In the PRP groups, venous blood will be drawn postoperatively and sent to Erciyes University Medical Faculty laboratories for PRP preparation. PRP will be centrifuged according to the manufacturer's specifications, transferred to sterile eye drop bottles, and given to the patients for application. Since PRP maintains its efficacy for seven days, a second blood draw and PRP preparation will be conducted during the first-week follow-up.
Follow-up and Assessments:
Patients will be evaluated on days 3, 7, 14, and 30 postoperatively. Pain assessment: Visual Analog Scale (VAS) will be used. Wound healing assessment: The surgical area will be stained with two-tone dye, standardized photographs will be taken, and the Healing Index (Landry et al.) will be used to evaluate healing on a 1-5 scale (1: very poor, 5: excellent).
At the one-month follow-up after gingivectomy, plaque index, gingival index, probing depth, and attachment loss measurements will be repeated.
This study aims to provide insights into the impact of PRP application on postoperative recovery and patient outcomes.
- Conditions
- Gingival Overgrowth
- Being tested
- PRP, Placebo
- Keywords
- gingival overgrowth, PRP, Gingivectomy, Wound Healing
- Medical subject headings
- Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPOther
venous blood will be drawn postoperatively and sent to Erciyes University Medical Faculty laboratories for PRP preparation. PRP will be centrifuged according to the manufacturer's specifications, transferred to sterile eye drop bottles, and given to the patients for application. Since PRP maintains its efficacy for seven days, a second blood draw and PRP preparation will be conducted during the first-week follow-up.
PlaceboOther
Patients will be provided with sterile eye drop bottles containing physiological saline and instructed to apply 3-4 drops to the wound site four times a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group) | No intervention | Standard post-gingivectomy protocol without any agent applied to the surgical site |
| Group 2 (Placebo) | Placebo comparator | Standard protocol with 3-4 drops of physiological saline applied to the surgical site, four times a day, for 14 days. Receives: Other: Placebo |
| Group 3 (PRP Kit 1) | Active comparator | Standard protocol with PRP prepared using Kit 1, applied to the surgical site in the same manner as the placebo group. Receives: Other: PRP |
| Group 4 (PRP Kit 2) | Active comparator | Standard protocol with PRP prepared using Kit 2, applied to the surgical site in the same manner as the placebo group. Receives: Other: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of wound healing
The wound area was stained with two-tone dye, and standardized photographs will be taken. Wound healing then was evaluated using the Healing Index (Landry et al.) based on the photographs. The Healing Index is designed on a 1-5 scale, where 1 indicates very poor healing, and 5 indicates excellent healing.
Measured: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure
Secondary outcomes (5)
Periodontal changes
Plaque Index (PI): To determine the level of plaque accumulation.
Measured: Before the initial periodontal treatment and at the first month after gingivectomy
postoperative pain
Postoperative pain experienced by the patients was assessed using the Visual Analog Scale (VAS). An independent doctor assessed the pain score by using minimum 0, maximum 10 scores with 10-cm unscaled visual analog scale (VAS).
Measured: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure
Periodontal changes
Gingival Index (GI): To assess gingival inflammation.
Measured: Before the initial periodontal treatment and at the first month after gingivectomy
Periodontal changes
Clinical Attachment Loss (CAL): To evaluate the extent of attachment loss.
Measured: Before the initial periodontal treatment and at the first month after gingivectomy
Periodontal changes
Probing Depth (PD): To measure the depth of periodontal pockets.
Measured: Before the initial periodontal treatment and at the first month after gingivectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start2 Jun 2021
- Primary completion2 Jun 2024
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival OvergrowthStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duygu Kilic
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Sponsor-investigator, Duygu Kilic, TC Erciyes University
- Investigators
- Duygu Kılıç, Principal investigator, Erciyes University Faculty of Dentistry Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124143
- Sponsor's protocol ID
- 56733164/203
- Acronym
- PRP
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet-Rich Plasma on Wound Healing After Gingivectomy: A Randomized Clinical Prospective Study
- ClinicalTrials.gov ID
- NCT07124143
- Acronym / sponsor ID
- PRP / 56733164/203
- Conditions
- Gingival Overgrowth
- Keywords
- gingival overgrowth, PRP, Gingivectomy, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duygu KilicUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 15 Aug 2025 (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 aim of the study is to evaluate the effects of using droplet-form platelet-rich plasma (PRP), known to have positive effects during the intermediate healing process, on wound healing in areas left for secondary healing after gingivectomy.
After the gingivectomy procedure, patients will be divided into four groups, each consisting of 10 individuals:
Group 1 (Control Group): This group will follow the standard post-gingivectomy protocol without any agent applied to the surgical site.
Group 2 (Placebo Group): In this group, the standard protocol will be followed, and physiological saline will be applied to the surgical site in 3-4 drops, four times a day, for 14 days.
Groups 3 and 4 (Study Groups): These groups will follow the standard protocol, with PRP prepared using different kits applied to the surgical site in 3-4 drops, four times a day, for 14 days.
All patients in the groups will be evaluated on the 3rd, 7th, 14th, and 30th days after the gingivectomy procedure. Postoperative pain will be assessed using the Visual Analog Scale (VAS), while wound healing will be evaluated using the Healing Index (Landry et al.) based on photographs of the region. Before taking standardized photographs, the surgical area will be stained with two-tone dye.
Detailed description
The aim of this study is to evaluate the effectiveness of platelet-rich plasma (PRP) prepared with different kits in improving the healing rate and enhancing patient comfort during the recovery process in the secondary healing areas following gingivectomy.
Systemically healthy individuals, patients with inflammatory gingival overgrowth, patients without periodontal treatment in the operative area within the last year, non-smokers and patients with intact periodontal structures will be included to the study. Also pregnant or breastfeeding patients, Patients below 18 or above 55 ages, smoking patients, patients with systemic diseases and who received periodontal treatment in the operative area within the last year and who use of medications causing gingival overgrowth will be excluded from the study.
Methodology:
A total of 40 patients meeting the inclusion criteria and willing to participate in the study will be recruited from those attending the Periodontology Clinic at Erciyes University Faculty of Dentistry for gum disease treatment.
Initial Procedures:
All participants will undergo initial periodontal treatment, including scaling and root planing. Periodontal assessments (plaque index, gingival index, probing depth, and attachment loss) will be performed before the initial treatment and at the first month post-treatment.
Study Procedure:
One month after the completion of initial periodontal therapy, gingivectomy will be performed, and the operative sites will be left for secondary healing. Before the procedure, the Pressure Pain Threshold Measurement will be taken for all patients using an algometer.
Participants will be randomly assigned to one of four groups:
Group 1 (Control group): Standard post-gingivectomy protocol without any agent applied to the surgical site.
Group 2 (Placebo): Standard protocol with 3-4 drops of physiological saline applied to the surgical site, four times a day, for 14 days.
Group 3 (PRP Kit 1): Standard protocol with PRP prepared using Kit 1, applied to the surgical site in the same manner as the placebo group.
Group 4 (PRP Kit2): Standard protocol with PRP prepared using Kit 2, applied similarly.
Postoperative Care:
All patients will be prescribed ibuprofen 600 mg (three times daily for three days). Placebo group patients will receive physiological saline in sterile eye drop bottles to apply as instructed.
In the PRP groups, venous blood will be drawn postoperatively and sent to Erciyes University Medical Faculty laboratories for PRP preparation. PRP will be centrifuged according to the manufacturer's specifications, transferred to sterile eye drop bottles, and given to the patients for application. Since PRP maintains its efficacy for seven days, a second blood draw and PRP preparation will be conducted during the first-week follow-up.
Follow-up and Assessments:
Patients will be evaluated on days 3, 7, 14, and 30 postoperatively. Pain assessment: Visual Analog Scale (VAS) will be used. Wound healing assessment: The surgical area will be stained with two-tone dye, standardized photographs will be taken, and the Healing Index (Landry et al.) will be used to evaluate healing on a 1-5 scale (1: very poor, 5: excellent).
At the one-month follow-up after gingivectomy, plaque index, gingival index, probing depth, and attachment loss measurements will be repeated.
This study aims to provide insights into the impact of PRP application on postoperative recovery and patient outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control group) | No intervention | –Standard post-gingivectomy protocol without any agent applied to the surgical site |
| Group 2 (Placebo) | Placebo comparator | Other: PlaceboStandard protocol with 3-4 drops of physiological saline applied to the surgical site, four times a day, for 14 days. |
| Group 3 (PRP Kit 1) | Active comparator | Other: PRPStandard protocol with PRP prepared using Kit 1, applied to the surgical site in the same manner as the placebo group. |
| Group 4 (PRP Kit 2) | Active comparator | Other: PRPStandard protocol with PRP prepared using Kit 2, applied to the surgical site in the same manner as the placebo group. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systemically healthy individuals
- Patients with inflammatory gingival overgrowth
- Patients who have not received periodontal treatment in the area to be treated within the last year
- Non-smokers
- Patients with intact periodontal structures
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Age under 18 or over 55
- Smoking
- Presence of systemic diseases
- Patients who have received periodontal treatment in the area to be treated within the last year
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 |
|---|---|---|
| PRPvenous blood will be drawn postoperatively and sent to Erciyes University Medical Faculty laboratories for PRP preparation. PRP will be centrifuged according to the manufacturer's specifications, transferred to sterile eye drop bottles, and given to the patients for application. Since PRP maintains its efficacy for seven days, a second blood draw and PRP preparation will be conducted during the first-week follow-up. | Other | Group 3 (PRP Kit 1), Group 4 (PRP Kit 2) |
| PlaceboPatients will be provided with sterile eye drop bottles containing physiological saline and instructed to apply 3-4 drops to the wound site four times a day for 14 days. | Other | Group 2 (Placebo) |
Primary outcome
The amount of wound healing
Time frame: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure
The wound area was stained with two-tone dye, and standardized photographs will be taken. Wound healing then was evaluated using the Healing Index (Landry et al.) based on the photographs. The Healing Index is designed on a 1-5 scale, where 1 indicates very poor healing, and 5 indicates excellent healing.
5 secondary outcomes
Periodontal changes
Time frame: Before the initial periodontal treatment and at the first month after gingivectomy
postoperative pain
Time frame: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure
Periodontal changes
Time frame: Before the initial periodontal treatment and at the first month after gingivectomy
Periodontal changes
Time frame: Before the initial periodontal treatment and at the first month after gingivectomy
Periodontal changes
Time frame: Before the initial periodontal treatment and at the first month after gingivectomy
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 15 Aug 2025.
- 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.
Duygu Kılıç principal investigator
Erciyes University Faculty of Dentistry Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Gingival Overgrowth, run by Duygu Kilic 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 5 inclusion and 6 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 15 Aug 2025. 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?
The amount of wound healing (time frame: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure). 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 15 Aug 2025.