The Effect of Platelet-Rich Plasma on Wound Healing After Gingivectomy

NCT07124143 | Completed

• 1 other identifier: 56733164/203
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gingival Overgrowth

Keywords

gingival overgrowth; PRP; Gingivectomy; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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.

  On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure

Secondary Outcomes (5)

• Periodontal changes

  Before the initial periodontal treatment and at the first month after gingivectomy

• postoperative pain

  On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure

• Periodontal changes

  Before the initial periodontal treatment and at the first month after gingivectomy

• Periodontal changes

  Before the initial periodontal treatment and at the first month after gingivectomy

• Periodontal changes

  Before the initial periodontal treatment and at the first month after gingivectomy

Other Outcomes (1)

• Pressure Pain Threshold - PPT

  Before the gingivectomy procedure

Study Arms (4)

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.

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.

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.

Other: PRP

Interventions

PRP OTHER

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.

Group 3 (PRP Kit 1); Group 4 (PRP Kit 2)

Placebo OTHER

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.

Group 2 (Placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duygu Kilic: lead
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University Faculty of Dentistry Department of Periodontology

Kayseri, Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Overgrowth

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Duygu Kılıç

  Erciyes University Faculty of Dentistry Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 15, 2025
• Study Start: June 2, 2021
• Primary Completion: June 2, 2024
• Study Completion: November 2, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)