Gingival OvergrowthNCT06865092
Comparison of I-PRF, T-PRF, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy.
A study testing injectable platelet-rich fibrin, titanium-prepared platelet-rich fibrin and Hyaluronic Acid (HA) in people with Gingival Overgrowth, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Objectives: This study aimed to evaluate the effect of injectable platelet-rich fibrin (i-prf), titanium-prepared platelet-rich fibrin (t-prf), and 0.8% hyaluronic acid (HA) gel on clinical periodontal parameters, wound healing, patient comfort and satisfaction after gingivectomy and gingivoplasty procedures routinely… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- injectable platelet-rich fibrin, titanium-prepared platelet-rich fibrin and Hyaluronic Acid (HA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Nov 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18-65 years of age
- Being systemically healthy
- Having chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior region, with no attachment and bone loss
- Not to have used any medication in the last three months
- Not smoking
- At least 20 natural teeth
Who cannot join
- Patients with orthodontic appliances
- Patients with removable (partial) prostheses
- Patients with immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs and/or drugs that may cause gingival enlargement use in the last 6 months
- Patients with oral and/or peri-oral pain
- Patients with significant oral lesions
- Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding
Show all 9Show fewer
- Patients who have undergone periodontal treatment within the last 6 months
- Patients with poor communication skills
- Smokers and alcohol users
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
Ankara, 06010
About this study
Official title: Comparison of Injectable Platelet-rich Fibrin, Titanium Platelet-rich Fibrin, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy and Gingivoplasty Operations: Randomized Controlled Clinical Study.
Objectives: This study aimed to evaluate the effect of injectable platelet-rich fibrin (i-prf), titanium-prepared platelet-rich fibrin (t-prf), and 0.8% hyaluronic acid (HA) gel on clinical periodontal parameters, wound healing, patient comfort and satisfaction after gingivectomy and gingivoplasty procedures routinely performed in the treatment of chronic inflammatory gingival overgrowth.
Materials and methods: In this clinical study, 60 systemically healthy patients with chronic inflammatory gingival overgrowth were randomly assigned to i-prf (n=15), t-prf (n=15), 0.8% HA (n=15), or control (n=15) groups and treated with gingivectomy and gingivoplasty after initial periodontal treatment. Pain and burning scores were evaluated with VAS 7 days after the procedures. Surgical areas were stained with Mira-2 tone and evaluated in ImageJ. Wound healing was evaluated using the Landry, Turnbull, and Howley (LTH) index and H2O2 foaming test at 7, 14, 21, and 28 days after the procedure. Clinical periodontal parameters assessed at baseline and 3 weeks after initial periodontal treatment were reassessed at 28 days following gingivectomy and gingivoplasty.
Read the detailed description
All patients diagnosed with chronic inflammatory gingival overgrowth based on clinical and radiological examinations underwent initial periodontal treatment (IPT) following baseline clinical periodontal assessments. Additionally, they received comprehensive oral hygiene instructions. After three weeks, patients were recalled for follow-up, and clinical periodontal parameters were re-evaluated. Gingivectomy and gingivoplasty surgery were planned.
Gingival growth was graded according to the following indices: The buccolingual aspect of gingival growth was classified according to the MB index (defined by Seymour and later modified by Miranda et al.) and the vertical aspect was classified according to the GOI index (defined by Angelopoulos and Goaz and later modified by Miller et al.). Patients presenting with a score greater than 0 in both indices were included in the study.
A total of four groups were planned in the study: one control group and three test groups.
- Test Group 1: Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.
- Test Group 2: Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.
- Test Group 3: Following gingivectomy with the conventional method, 0.8% HA (Gengigel; Ricerfarma, Milan, Italy) is applied to the wound site and covered with periodontal dressing.
- Control Group: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.
Clinical periodontal parameters were evaluated at baseline (T0), after IPT (T1), and in the 1st month after gingivectomy and gingivoplasty (T2). The gingival index (GI; Loe and Silness GI), plaque index (PI; Turesky-Gilmore-Glickman modification of the Quigley-Hein PI), bleeding on probing index (BOP), and probing depth (PD) were recorded. Using a Williams periodontal probe, the GI, BOP, and PD were assessed at six sites per tooth (excluding the third molar): three sites on the buccal surface (disto-buccal/labial, mesio-buccal/labial, and mid-buccal/labial) and three sites on the lingual surface (disto-lingual/palatal, mesio-lingual/palatal, and mid-lingual/palatal).
Conventional gingivectomy and gingivoplasty procedures were performed under local infiltration anesthesia. A 45-degree inclined external bevel incision was made using a surgical scalpel (Carbon, No. 15) and a gingivectomy blade (Hu-Friedy 15/16, Chicago, USA), starting from the distal end of the incision line. The interdental area was shaped using an Orban knife (Hu-Friedy 1/2, Chicago, USA), and any remaining granulation tissue was carefully removed from the surrounding area with curettes and scissors (Hu-Friedy, Chicago, USA). Finally, gingivoplasty was completed using a Kirkland knife (Hu-Friedy, Chicago, USA).
After the surgical procedures were completed, the control group areas were left to heal spontaneously. The other groups were treated with i-prf, t-prf, or 0.8% HA. Surgical areas in the control and test sites were covered with periodontal dressing (Coepak, Isip, IL, USA).
Patients were advised to avoid hot foods, to consume soft foods, and to keep the dressing in the mouth until the next examination. Patients were prescribed mouthwash containing 0.12% chlorhexidine and analgesic containing paracetamol to be used twice a day for one week.
- Conditions
- Gingival Overgrowth
- Being tested
- injectable platelet-rich fibrin, titanium-prepared platelet-rich fibrin, Hyaluronic Acid (HA), control group
- Keywords
- Gingival Overgrowth, Hyaluronic Acid, I-PRF, T-PRF, Gingivectomy
- Medical subject headings
- Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable platelet-rich fibrinBiological
Also called i-prf
Blood samples were collected in two 10 ml plastic tubes without anticoagulant. The tubes were centrifuged for 3 min at 2500 rpm in a centrifuge device and i-prf was obtained.
titanium-prepared platelet-rich fibrinBiological
Also called t-prf
The blood was drawn into a 20 ml syringe and immediately divided into two sterile grade IV titanium tubes containing 10 ml of blood. The tubes were placed opposite each other and centrifuged at 2700 rpm for 12 minutes at room temperature and t-prf was obtained.
Hyaluronic Acid (HA)Drug
Also called HA, 0.8% HA
0.8% hyaluronic acid (HA) gel (Gengigel) was applied to the wound sites.
control groupOther
Nothing has applied.
| Study group | Role | What they receive |
|---|---|---|
| •I-PRF Group | Experimental | Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing. Receives: Biological: injectable platelet-rich fibrin |
| • T-PRF Group | Experimental | Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing. Receives: Biological: titanium-prepared platelet-rich fibrin |
| •HA Group | Experimental | Following gingivectomy with the conventional method, 0.8% HA (Gengigel; Ricerfarma, Milan, Italy) is applied to the wound site and covered with periodontal dressing. Receives: Drug: Hyaluronic Acid (HA) |
| •Control Group | Experimental | : Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of wound epithelialization
Evaluation of wound epithelialization with Mira-2 tone Solution
Measured: after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28
LTH wound healing index
Assessment of soft tissue healing with Landry, Turnbull, and Howley (LTH) index
Measured: Day 7, Day 14, Day 21, Day 28
Secondary outcomes (7)
H2O2 foaming test
H2O2 foaming test (evaluation of wound epithelialization)
Measured: Day 7, Day 14, Day 21, Day 28
Pain and burning scores
Pain and burning scores were evaluated with VAS.
Measured: After gingivectomy Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Gingival index (GI)
Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Measured: Baseline, 3 weeks, Day 28 after gingivectomy
Plaque index (PI)
Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
Measured: Baseline, 3 weeks, Day 28 after gingivectomy
Bleeding on Probing (BOP)
Improvement in PBI; lower scores mean a better outcome; Minimum score: %0 Max.score: %100
Measured: Baseline, 3 weeks, Day 28 after gingivectomy
Pocket depth (PD)
Improvement in PD; lower scores mean a better outcome
Measured: Baseline, 3 weeks, Day 28 after gingivectomy
OHIP-14
Improvement in Oral Health Impact Profile (OHIP-14) ; lower scores mean a better outcome
Measured: Baseline, Day 7, Day 14 after gingivectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 May 2023
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
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.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Model description
- randomized controlled, single-blind, prospective clinical study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem SARAÇ ATAGÜN, Saglik Bilimleri Universitesi
- Investigators
- özlem saraç atagün, PhD, Principal investigator, Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865092
- Sponsor's protocol ID
- OSATAGUN3
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2025
- Last updated
- 23 Apr 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Injectable Platelet-rich Fibrin, Titanium Platelet-rich Fibrin, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy and Gingivoplasty Operations: Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT06865092
- Acronym / sponsor ID
- OSATAGUN3
- Conditions
- Gingival Overgrowth
- Keywords
- Gingival Overgrowth, Hyaluronic Acid, I-PRF, T-PRF, Gingivectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 7 Mar 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.
Objectives: This study aimed to evaluate the effect of injectable platelet-rich fibrin (i-prf), titanium-prepared platelet-rich fibrin (t-prf), and 0.8% hyaluronic acid (HA) gel on clinical periodontal parameters, wound healing, patient comfort and satisfaction after gingivectomy and gingivoplasty procedures routinely performed in the treatment of chronic inflammatory gingival overgrowth.
Materials and methods: In this clinical study, 60 systemically healthy patients with chronic inflammatory gingival overgrowth were randomly assigned to i-prf (n=15), t-prf (n=15), 0.8% HA (n=15), or control (n=15) groups and treated with gingivectomy and gingivoplasty after initial periodontal treatment. Pain and burning scores were evaluated with VAS 7 days after the procedures. Surgical areas were stained with Mira-2 tone and evaluated in ImageJ. Wound healing was evaluated using the Landry, Turnbull, and Howley (LTH) index and H2O2 foaming test at 7, 14, 21, and 28 days after the procedure. Clinical periodontal parameters assessed at baseline and 3 weeks after initial periodontal treatment were reassessed at 28 days following gingivectomy and gingivoplasty.
Detailed description
All patients diagnosed with chronic inflammatory gingival overgrowth based on clinical and radiological examinations underwent initial periodontal treatment (IPT) following baseline clinical periodontal assessments. Additionally, they received comprehensive oral hygiene instructions. After three weeks, patients were recalled for follow-up, and clinical periodontal parameters were re-evaluated. Gingivectomy and gingivoplasty surgery were planned.
Gingival growth was graded according to the following indices: The buccolingual aspect of gingival growth was classified according to the MB index (defined by Seymour and later modified by Miranda et al.) and the vertical aspect was classified according to the GOI index (defined by Angelopoulos and Goaz and later modified by Miller et al.). Patients presenting with a score greater than 0 in both indices were included in the study.
A total of four groups were planned in the study: one control group and three test groups.
- Test Group 1: Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.
- Test Group 2: Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.
- Test Group 3: Following gingivectomy with the conventional method, 0.8% HA (Gengigel; Ricerfarma, Milan, Italy) is applied to the wound site and covered with periodontal dressing.
- Control Group: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.
Clinical periodontal parameters were evaluated at baseline (T0), after IPT (T1), and in the 1st month after gingivectomy and gingivoplasty (T2). The gingival index (GI; Loe and Silness GI), plaque index (PI; Turesky-Gilmore-Glickman modification of the Quigley-Hein PI), bleeding on probing index (BOP), and probing depth (PD) were recorded. Using a Williams periodontal probe, the GI, BOP, and PD were assessed at six sites per tooth (excluding the third molar): three sites on the buccal surface (disto-buccal/labial, mesio-buccal/labial, and mid-buccal/labial) and three sites on the lingual surface (disto-lingual/palatal, mesio-lingual/palatal, and mid-lingual/palatal).
Conventional gingivectomy and gingivoplasty procedures were performed under local infiltration anesthesia. A 45-degree inclined external bevel incision was made using a surgical scalpel (Carbon, No. 15) and a gingivectomy blade (Hu-Friedy 15/16, Chicago, USA), starting from the distal end of the incision line. The interdental area was shaped using an Orban knife (Hu-Friedy 1/2, Chicago, USA), and any remaining granulation tissue was carefully removed from the surrounding area with curettes and scissors (Hu-Friedy, Chicago, USA). Finally, gingivoplasty was completed using a Kirkland knife (Hu-Friedy, Chicago, USA).
After the surgical procedures were completed, the control group areas were left to heal spontaneously. The other groups were treated with i-prf, t-prf, or 0.8% HA. Surgical areas in the control and test sites were covered with periodontal dressing (Coepak, Isip, IL, USA).
Patients were advised to avoid hot foods, to consume soft foods, and to keep the dressing in the mouth until the next examination. Patients were prescribed mouthwash containing 0.12% chlorhexidine and analgesic containing paracetamol to be used twice a day for one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized controlled, single-blind, prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| •I-PRF Group | Experimental | Biological: injectable platelet-rich fibrinFollowing gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing. |
| • T-PRF Group | Experimental | Biological: titanium-prepared platelet-rich fibrinFollowing gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing. |
| •HA Group | Experimental | Drug: Hyaluronic Acid (HA)Following gingivectomy with the conventional method, 0.8% HA (Gengigel; Ricerfarma, Milan, Italy) is applied to the wound site and covered with periodontal dressing. |
| •Control Group | Experimental | Other: control group: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18-65 years of age
- Being systemically healthy
- Having chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior region, with no attachment and bone loss
- Not to have used any medication in the last three months
- Not smoking
Key exclusion criteria (9 listed)
- Patients with orthodontic appliances
- Patients with removable (partial) prostheses
- Patients with immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs and/or drugs that may cause gingival enlargement use in the last 6 months
- Patients with oral and/or peri-oral pain
- Patients with significant oral lesions
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 |
|---|---|---|
| injectable platelet-rich fibrinAlso: i-prfBlood samples were collected in two 10 ml plastic tubes without anticoagulant. The tubes were centrifuged for 3 min at 2500 rpm in a centrifuge device and i-prf was obtained. | Biological | •I-PRF Group |
| titanium-prepared platelet-rich fibrinAlso: t-prfThe blood was drawn into a 20 ml syringe and immediately divided into two sterile grade IV titanium tubes containing 10 ml of blood. The tubes were placed opposite each other and centrifuged at 2700 rpm for 12 minutes at room temperature and t-prf was obtained. | Biological | • T-PRF Group |
| Hyaluronic Acid (HA)Also: HA, 0.8% HA0.8% hyaluronic acid (HA) gel (Gengigel) was applied to the wound sites. | Drug | •HA Group |
| control groupNothing has applied. | Other | •Control Group |
Primary outcome
Evaluation of wound epithelialization
Time frame: after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28
Evaluation of wound epithelialization with Mira-2 tone Solution
LTH wound healing index
Time frame: Day 7, Day 14, Day 21, Day 28
Assessment of soft tissue healing with Landry, Turnbull, and Howley (LTH) index
7 secondary outcomes
H2O2 foaming test
Time frame: Day 7, Day 14, Day 21, Day 28
Pain and burning scores
Time frame: After gingivectomy Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Gingival index (GI)
Time frame: Baseline, 3 weeks, Day 28 after gingivectomy
Plaque index (PI)
Time frame: Baseline, 3 weeks, Day 28 after gingivectomy
Bleeding on Probing (BOP)
Time frame: Baseline, 3 weeks, Day 28 after gingivectomy
Pocket depth (PD)
Time frame: Baseline, 3 weeks, Day 28 after gingivectomy
OHIP-14
Time frame: Baseline, Day 7, Day 14 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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
özlem saraç atagün, PhD principal investigator
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injectable platelet-rich fibrin, titanium-prepared platelet-rich fibrin and Hyaluronic Acid (HA) in people with Gingival Overgrowth, run by Saglik Bilimleri Universitesi 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 6 inclusion and 9 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 23 Apr 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 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. 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?
Evaluation of wound epithelialization (time frame: after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28). The study lists 2 primary outcomes in all. 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 23 Apr 2026.