Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT07174934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of I-PRF After Gingivectomy
Sponsor:
Faculty of Dental Medicine for Girls
Organization:
Study Overview
Official Title:
Evaluation of The Effect of Injectable Platelet-Rich Fibrin Application on Wound Healing Following Gingivectomy or Gingivoplasty: Randomized Controlled Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-PRF
Brief Summary:
The goal of this clinical trial is to evaluate the effect of injectable platelet-rich fibrin application on wound healing following gingivectomy or gingivoplasty.
The main question it aims to answer are:
Does the injectable platelet-rich fibrin enhance the wound healing after gingivectomy or gingivoplasty ?
Participants(who have chronic inflammatory gingival overgrowth) will be divided into two groups :
Group I: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty alone (control).
Group II: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty and application of injectable platelet rich fibrin on wound area.
The patients will be recalled for follow-up appointments on days 7, 14, and 21.
The main question it aims to answer are:
Does the injectable platelet-rich fibrin enhance the wound healing after gingivectomy or gingivoplasty ?
Participants(who have chronic inflammatory gingival overgrowth) will be divided into two groups :
Group I: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty alone (control).
Group II: systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty and application of injectable platelet rich fibrin on wound area.
The patients will be recalled for follow-up appointments on days 7, 14, and 21.
Detailed Description:
All participants will receive a full-mouth clinical examination, Initial periodontal therapy and oral hygiene instructions. the patients will be called again 2 weeks later after phase I therapy.
The following periodontal parameters will be recorded: Plaque Index (PI) , Bleeding on probing (BOP) before and after surgery operation at (baseline, 21day).
Prior to the procedure, patients will be rinsed with mouthwash containing 0.12% chlorhexidine. Surgical operations will be carried out with local infiltration anesthesia with vasoconstrictor the gingivectomy or gingivoplasty operation will be done with the conventional method (the procedure of gingivectomy with a #15 scalpel), then Test group: I-PRF is placed on the wound area after a gingivectomy or gingivoplasty with the conventional method and closed with a periodontal dressing.
Control group: closure of the wound area with only a periodontal dressing after a gingivectomy or gingivoplasty with the conventional method.
Post-operative instructions will be given and patients will be asked to avoid brushing at the surgical sites for at least 7 days, 0.2% chlorhexidine gluconate mouthwash twice daily for 14 days will be prescribed.
Clinical follow-up of patients:
The patients will be recalled for follow-up appointments on days 7, 14, and 21. The parameters evaluated in the control sessions were as follows:
1. LTH wound healing index : there are many parameters to assess wound healing, but the Landry, Turnbull, and Hawley Index is easy and convenient to score . It has a scoring range from 1 to 5, the lowest being 1 and the highest being 5. The parameters measured in this index are the healing index, tissue color, bleeding on palpation, granulation tissue, and suppuration .
2. MMS scale : the modified Manchester scar scale (MSS) was used to assess the color, contour, and distortion of the wound .
The color of the wound was classified as a perfect match (score 0), mild mismatch (score 1), or obvious mismatch (score 2) compared with the neighboring mucosa. The contour of the wound was evaluated as similar (score0), slightly raised, or indented (score 1) and hypertrophic (score2) when compared with surrounding tissues. Wound distortion was evaluated as no distortion (score 0), mild distortion (score 1), and obvious distortion (score 2). The sum of the scores in the three categories shows the repair score of the wound, with a total score ranging from 0 to 6, with lower scores indicating better repair.
3. Visual Analog Scale : Assessment patient satisfaction very important so, post operative pain will be evaluated by visual analog scale (VAS) . In this method, the patients will be asked to rate their pain at an examination in form of a score between 0 (no pain) and 100 (the most pain which patient has ever experienced) .
Gingival fluid sampling :
Gingival crevicular fluid (GCF) collection will be done before the operation (at base line), and after the operation (21th day). samples will be collected using sterile paper strips, Paper strips contaminated with blood or saliva will be discarded.
The samples will be assayed for PRL by using an enzyme linked immunosorbent assay (ELISA) kits.
full-mouth clinical examination, Initial periodontal therapy, clinical measurements, surgery operation, gingival crevicular fluid sampling and follow-up evaluations will be performed by the same periodontist.
The following periodontal parameters will be recorded: Plaque Index (PI) , Bleeding on probing (BOP) before and after surgery operation at (baseline, 21day).
Prior to the procedure, patients will be rinsed with mouthwash containing 0.12% chlorhexidine. Surgical operations will be carried out with local infiltration anesthesia with vasoconstrictor the gingivectomy or gingivoplasty operation will be done with the conventional method (the procedure of gingivectomy with a #15 scalpel), then Test group: I-PRF is placed on the wound area after a gingivectomy or gingivoplasty with the conventional method and closed with a periodontal dressing.
Control group: closure of the wound area with only a periodontal dressing after a gingivectomy or gingivoplasty with the conventional method.
Post-operative instructions will be given and patients will be asked to avoid brushing at the surgical sites for at least 7 days, 0.2% chlorhexidine gluconate mouthwash twice daily for 14 days will be prescribed.
Clinical follow-up of patients:
The patients will be recalled for follow-up appointments on days 7, 14, and 21. The parameters evaluated in the control sessions were as follows:
1. LTH wound healing index : there are many parameters to assess wound healing, but the Landry, Turnbull, and Hawley Index is easy and convenient to score . It has a scoring range from 1 to 5, the lowest being 1 and the highest being 5. The parameters measured in this index are the healing index, tissue color, bleeding on palpation, granulation tissue, and suppuration .
2. MMS scale : the modified Manchester scar scale (MSS) was used to assess the color, contour, and distortion of the wound .
The color of the wound was classified as a perfect match (score 0), mild mismatch (score 1), or obvious mismatch (score 2) compared with the neighboring mucosa. The contour of the wound was evaluated as similar (score0), slightly raised, or indented (score 1) and hypertrophic (score2) when compared with surrounding tissues. Wound distortion was evaluated as no distortion (score 0), mild distortion (score 1), and obvious distortion (score 2). The sum of the scores in the three categories shows the repair score of the wound, with a total score ranging from 0 to 6, with lower scores indicating better repair.
3. Visual Analog Scale : Assessment patient satisfaction very important so, post operative pain will be evaluated by visual analog scale (VAS) . In this method, the patients will be asked to rate their pain at an examination in form of a score between 0 (no pain) and 100 (the most pain which patient has ever experienced) .
Gingival fluid sampling :
Gingival crevicular fluid (GCF) collection will be done before the operation (at base line), and after the operation (21th day). samples will be collected using sterile paper strips, Paper strips contaminated with blood or saliva will be discarded.
The samples will be assayed for PRL by using an enzyme linked immunosorbent assay (ELISA) kits.
full-mouth clinical examination, Initial periodontal therapy, clinical measurements, surgery operation, gingival crevicular fluid sampling and follow-up evaluations will be performed by the same periodontist.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: