An interventional study of PRP and Placebo in Gingival Overgrowth, sponsored by Duygu Kilic. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Duygu Kilic · Not applicable, Interventional, and Supportive care
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.
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.
22 studies on the registry are indexed under Gingival Overgrowth; 2 are open to participants now.
This study's enrollment of 38 is above the median of 30 across 20 interventional studies indexed under Gingival Overgrowth.
Browse Gingival Overgrowth studies →This is the only study on the registry with Duygu Kilic as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard post-gingivectomy protocol without any agent applied to the surgical site
Standard protocol with 3-4 drops of physiological saline applied to the surgical site, four times a day, for 14 days.
Other: Placebo
Standard protocol with PRP prepared using Kit 1, applied to the surgical site in the same manner as the placebo group.
Other: PRP
Standard protocol with PRP prepared using Kit 2, applied to the surgical site in the same manner as the placebo group.
Other: PRP
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.
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.
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.
Time frame: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure
Periodontal changes
Plaque Index (PI): To determine the level of plaque accumulation.
Time frame: 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).
Time frame: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure
Periodontal changes
Gingival Index (GI): To assess gingival inflammation.
Time frame: 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.
Time frame: Before the initial periodontal treatment and at the first month after gingivectomy
Periodontal changes
Probing Depth (PD): To measure the depth of periodontal pockets.
Time frame: Before the initial periodontal treatment and at the first month after gingivectomy
Pressure Pain Threshold - PPT
An examiner touched the tip of the dial tension gauge perpendicular to the surface of the attached gingival mucosa at the midline of the maxilla and mandible. After a trial, the process was repeated three times with a 3-minute interval between measurements. The average of the three values was taken for statistical analysis.
Time frame: Before the gingivectomy procedure
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.