Chronic Inflammatory Gingival EnlargementI-PRFNCT07174934
Effect of I-PRF After Gingivectomy
A study testing application of injectable platelet-rich fibrin on the wound area . in people with Chronic Inflammatory Gingival Enlargement, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial 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 ?… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Gingival Enlargement
- What is being tested?
- application of injectable platelet-rich fibrin on the wound area .
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2025to 28 Jun 2026
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Systemically healthy patients. 2- patients ages18-35years. 3- patients with chronic inflammatory gingival overgrowth. 4- patients with fibrotic gingival overgrowth. 5- Patients with enough attached gingiva. 6- Patients signing informed written consent.
Who cannot join
- 1) Pregnancy or lactation. 2) Any known systemic disease. 3) Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months.
- 4) smokers and alcohol users 5) clinical attachment or bone loss. 6) Patients run on 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Out-Patient Clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dental Medicine for Girls, Al-Azhar University.
Cairo
About this study
Official title: Evaluation of The Effect of Injectable Platelet-Rich Fibrin Application on Wound Healing Following Gingivectomy or Gingivoplasty: Randomized Controlled Clinical Study
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:
Read more
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.
Read the 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:
- 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 .
- 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.
- 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.
- Being tested
- application of injectable platelet-rich fibrin on the wound area .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of injectable platelet-rich fibrin on the wound area .Biological
Injectable platelet-rich fibrin will be prepared using low speed centrifugation technique, after centrifugation, the I-PRF in the upper part of the tube will be collected via an injector and will be transferred to a metal godet. It will be left for 15-20 min for polymerization of the I-PRF ,Then the polymerized I-PRF will be applied to the secondary wound of test area.
| Study group | Role | What they receive |
|---|---|---|
| application of injectable platelet-rich fibrin after gingivectomy or gingivoplasty . | Active comparator | 10 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. Receives: Biological: application of injectable platelet-rich fibrin on the wound area . |
| gingivectomy or gingivoplasty alone | No intervention | 10 systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty alone (control). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival crevicular fluid level of Vascular Endothelial Growth Factor (VEGF) at baseline and 21 days after gingivectomy or gingivoplasty.
Measured: at baseline, 21days after gingivectomy.
Secondary outcomes (3)
Patient satisfaction using Visual Analog Scale (VAS).
Scale Range: 0 (not satisfied at all) to 10 (completely satisfied).
Measured: At 7th ,14th,21th days after gingivectomy.
Clinical wound healing using Landry, Turnbull, and Howley (LTH) Wound Healing Index.
Scale Range: 1 (very poor healing) to 5 (excellent healing).
Measured: 7th, 14th, 21st days after gingivectomy.
Clinical wound healing using Modified Manchester Scar (MMS) Scale.
Measured: 7th, 14th, 21st days after gingivectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start5 Oct 2025
- Primary completion12 May 2026
- Study completion28 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Gingival EnlargementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eman Ahmed Elgharib Ahmed, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174934
- Sponsor's protocol ID
- P-ME-25-07
- Acronym
- I-PRF
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Injectable Platelet-Rich Fibrin Application on Wound Healing Following Gingivectomy or Gingivoplasty: Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07174934
- Acronym / sponsor ID
- I-PRF / P-ME-25-07
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 28 Jun 2026 (actual)
- First posted
- 16 Sep 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 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.
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:
- 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 .
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| application of injectable platelet-rich fibrin after gingivectomy or gingivoplasty . | Active comparator | Biological: application of injectable platelet-rich fibrin on the wound area .10 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. |
| gingivectomy or gingivoplasty alone | No intervention | –10 systemically healthy patients with chronic inflammatory gingival enlargement will be randomly treated with gingivectomy or gingivoplasty alone (control). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- Systemically healthy patients. 2- patients ages18-35years. 3- patients with chronic inflammatory gingival overgrowth. 4- patients with fibrotic gingival overgrowth. 5- Patients with enough attached gingiva. 6- Patients signing informed written consent.
Key exclusion criteria (2 listed)
- 1) Pregnancy or lactation. 2) Any known systemic disease. 3) Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months.
- 4) smokers and alcohol users 5) clinical attachment or bone loss. 6) Patients run on 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.
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 |
|---|---|---|
| application of injectable platelet-rich fibrin on the wound area .Injectable platelet-rich fibrin will be prepared using low speed centrifugation technique, after centrifugation, the I-PRF in the upper part of the tube will be collected via an injector and will be transferred to a metal godet. It will be left for 15-20 min for polymerization of the I-PRF ,Then the polymerized I-PRF will be applied to the secondary wound of test area. | Biological | application of injectable platelet-rich fibrin after gingivectomy or gingivoplasty . |
Primary outcome
Change in gingival crevicular fluid level of Vascular Endothelial Growth Factor (VEGF) at baseline and 21 days after gingivectomy or gingivoplasty.
Time frame: at baseline, 21days after gingivectomy.
3 secondary outcomes
Patient satisfaction using Visual Analog Scale (VAS).
Time frame: At 7th ,14th,21th days after gingivectomy.
Clinical wound healing using Landry, Turnbull, and Howley (LTH) Wound Healing Index.
Time frame: 7th, 14th, 21st days after gingivectomy.
Clinical wound healing using Modified Manchester Scar (MMS) Scale.
Time frame: 7th, 14th, 21st days 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 27 Aug 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of injectable platelet-rich fibrin on the wound area . in people with Chronic Inflammatory Gingival Enlargement, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
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 2 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 27 Aug 2026. 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 Egypt. 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. 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?
Change in gingival crevicular fluid level of Vascular Endothelial Growth Factor (VEGF) at baseline and 21 days after gingivectomy or gingivoplasty. (time frame: at baseline, 21days after gingivectomy.). 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 27 Aug 2026.