PeriodontitisNCT06605547
The Effect of I-PRF As An Adjunct to Non-Surgical Periodontal Therapy on Clinical Parameters in Smokers With Periodontitis
A study testing Non-surgical periodontal treatment, Subgingival application of saline and Subgingival application of i-PRF in people with Periodontitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to evaluate the effect of subgingival injectable platelet-rich fibrin (i-PRF) application on clinical periodontal parameters as an adjunct to non-surgical periodontal treatment (NSPT) in smokers with periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non-surgical periodontal treatment, Subgingival application of saline and Subgingival application of i-PRF
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2023to 30 Apr 2024
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients were systemically healthy adults,
- having at least 20 natural teeth,
- the presence of contralateral periodontal pockets (PPD≥ 5 mm) and CAL≥2 mm on a minimum of two premolar/molar teeth on each side and no furcation involvement,
- smoking more than 10 cigarettes per day for at least 5 years,
- stage II-III periodontitis patients
Who cannot join
- individuals had past periodontal treatment within 6 months
- individuals had used systemic antibiotics in the last 6 months or anti- inflammatory drugs in the last 3 months before the beginning of the trial,
- patient with clotting and hematologic disorders, had used drugs affecting the natural coagulation process,
- patients taking medications that affect the gingival and periodontal tissues
- pregnant or breastfeeding females
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, 14030
About this study
Official title: The Effect of Injectable Platelet-Rich Fibrin As An Adjunct to Non-Surgical Periodontal Therapy on Clinical Parameters in Smokers With Periodontitis: A Split-Mouth Randomized Controlled Trial
The aim of this clinical trial is to evaluate the effect of subgingival injectable platelet-rich fibrin (i-PRF) application on clinical periodontal parameters as an adjunct to non-surgical periodontal treatment (NSPT) in smokers with periodontitis.
Twenty-five systemically healthy, smoker patients with stage II/III periodontitis were included in the study. In this split-mouth trial, subgingival i-PRF was applied to the test group in addition to NSPT, while saline was applied to the control group after NSPT. Subgingival i-PRF/saline application was repeated on the 7th day in both groups. Clinical periodontal parameters were recorded at baseline, 1st and 3rd months after the treatment.
Read the detailed description
Twenty-five systemically healthy, smoker patients with periodontitis were included in the study. All individuals were examined at baseline, 1st and 3rd months after non-surgical periodontal treatment including, whole mouth probing pocket depth (PPD), clinical attachment loss (CAL), presence of bleeding on probing (BOP), gingival index (GI) and Turesky Modified Quigley-Hein Plaque Index (TQHPI) except the third molars. PPD and CAL were measured at six sites per tooth using a manual periodontal probe. All measurements and NSPT were performed by the same blinded and calibrated examiner (TCG).
The NSPT included supra- and subgingival scaling, root planing and oral hygiene instructions. Subgingival scaling and root planing were performed under local anesthesia within the 24 h. After NSPT, four contralateral deep pockets (two for each side) in premolar/molar ares were determined. The sites were randomly divided into test sites receiving the subgingival application of i-PRF and controls treated with saline.
After the NSPT was completed, the i-PRF was produced as follows: 9 mL of whole blood was collected from the antecubital vein in a sterile plastic tubes without anticoagulant and immediately centrifuged at 700 rpm for 3 minutes with a centrifuge device. After centrifugation, the upper liquid layer was collected as i-PRF and placed into an insulin syringe connected to a 29G needle.
Before the i-PRF application, the teeth were isolated with a cotton roll and dried with a cotton pellet. The 29-gauge needle tip was gently placed into the periodontal pocket and the i-PRF was injected into the periodontal pocket until it reached the gingival margin (until it overflowed from the sulcus). For the subgingival saline application, the insulin syringe was filled with saline and the 29-gauge needle tip was gently placed into the periodontal pocket. The saline was injected into the periodontal pocket until it was seen to overflow from the gingival margin. After the subgingival application of i-PRF/saline , the application areas were isolated and waited for 10 minutes in order to prevent the i-PRF from being removed from the sulcus with oral fluids until it turned into a gel. Subgingival i-PRF/salin application was performed by a periodontist (BMY).Patients were instructed not to drink or eat anything, including water, for at least 30 minutes after the procedure. Patients were informed about oral hygiene practices (tooth brushing and interdental cleaning) and were motivated to perform daily oral care. Patients were given an appointment for the second application of i-PRF/salin application 7 days later. In this session, i-PRF/salin application was applied to the previously applied areas, oral hygiene was checked and patients were informed again. Patients were called again in the 1st and 3rd months, periodontal clinical measurements were repeated and oral hygiene motivation was given.
Statistical analyses were performed using a statistical analysis software (SPSS v.25.0; IBM). The Shapiro Wilk test was used to determine the normality of the present data and the variance homogeneity was checked with the Levene test. For non-normally distributed data, the Mann Whitney U test was used for pairwise comparison. The Independent Samples T test was performed for normally distributed data. The Friedman test was used to examine the differences between three dependent groups. Bonferroni correction was performed for multiple variations. The statistical significance value was accepted as p \< 0.05.
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal treatment, Subgingival application of saline, Subgingival application of i-PRF
- Keywords
- smoker, periodontitis, i-PRF
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
The non-surgical periodontal treatment (scaling and root planing) was applied under local anesthesia using ultrasonic device and Gracey curettes. After scaling and root planing, periodontal pockets were irrigated using saline solution. Non-surgical periodontal treatment was completed in one or two sessions within 24 hours.
Subgingival application of salineDevice
For the subgingival saline application at the control sites, the insulin needle was filled with saline and the 29-gauge needle tip was gently placed into the periodontal pocket. The saline was injected into the periodontal pocket until it was seen to overflow from the gingival margin. Subgingival saline application was repeated on the 7th day.
Subgingival application of i-PRFOther
For subgingival application of i-PRF at the test sites, the i-PRF taken into the insulin syringe, the 29-gauge needle tip was gently placed into the periodontal pocket and the i-PRF was injected into the periodontal pocket until it reached the gingival margin (until it overflowed from the sulcus). Subgingival i-PRF application was repeated on the 7th day.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | Test sites receiving the subgingival application of i-PRF after NSPT. Receives: Procedure: Non-surgical periodontal treatment; Other: Subgingival application of i-PRF |
| Control group | Placebo comparator | Control sites treated with saline after NSPT. Receives: Procedure: Non-surgical periodontal treatment; Device: Subgingival application of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment loss (CAL)
CAL measured as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus (the most coronal attachment) using a Williams periodontal probe. The changes in clinical attachment loss was measured for determining the severity of disease.
Measured: Baseline, 1st and 3rd months
Probing pocket depth (PPD)
PPD measured as the change in distance from the gingival margin to the bottom of the gingival sulcus using a Williams periodontal probe. The changes in PPD was measured for determining of the severity of disease and clinical outcome.
Measured: Baseline, 1st and 3rd months
Secondary outcomes (3)
Bleeding on probing (BOP)
All six sites of all teeth were probed to assess whether this elicited bleeding (+) or not (-). The severity of gingival inflammation was expressed as a percentage (BOP=number of bleeding sites×100/number of sites evaluated). Bleeding on probing was recorded for classifying and evaluating gingival inflammation
Measured: Baseline, 1st and 3rd months
Turesky Modified Quigley-Hein Plaque Index (TQHPI)
TQHPI for the entire mouth was determined by dividing the total score by the number of surfaces examined. Scoring was as follows:
- 0: no plaque
- 1: separate flecks of plaque at the cervical margin of the tooth
- 2: a thin continuous band of plaque (≤ 1 mm) at the cervical margin of the tooth
- 3: a band of plaque \> 1 mm but covering less than one-third of the crown of the tooth
- 4: plaque covering at least one-third but less than two- thirds of the crown of the tooth
- 5: plaque covering two-thirds or more of the crown of the tooth labial/buccal and lingual surfaces assessed after using a disclosing solution.
TQHPI was recorded for determining and classifying oral hygiene status.
Measured: Baseline, 1st and 3rd months
Gingival index (GI)
To determine the gingival index (Löe \& Silness), gingival bleeding caused by running a Williams periodontal probe inside the pocket on the mesial, distal, buccal, and palatal surfaces of all teeth was evaluated. The gingival index of an individual was obtained by summing the values determined for each tooth and calculating the averages. Scoring was as follows:
- 0: Healthy gums.
- 1: Mild discolouration and oedematous gingiva. No bleeding on probing.
- 2: Red, oedematous and shiny gingiva. There is bleeding on probing.
- 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding. Gingival index was recorded for classifying and evaluating sulcular gingival inflammation.
Measured: Baseline, 1st and 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start4 Sep 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Split-mouth, randomized controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge MERACI YILDIRAN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605547
- Sponsor's protocol ID
- BAIBU-SBF-BMY-01
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cagiran Gurbuz T, Meraci Yildiran B. The clinical efficacy of injectable platelet-rich fibrin (i-PRF) as an adjunct to nonsurgical periodontal therapy in smokers with periodontitis. BMC Oral Health. 2025 Apr 23;25(1):618. doi: 10.1186/s12903-025-06019-w.
PubMed 40269777
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Injectable Platelet-Rich Fibrin As An Adjunct to Non-Surgical Periodontal Therapy on Clinical Parameters in Smokers With Periodontitis: A Split-Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06605547
- Acronym / sponsor ID
- BAIBU-SBF-BMY-01
- Conditions
- Periodontitis
- Keywords
- smoker, periodontitis, i-PRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Sep 2024 (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 aim of this clinical trial is to evaluate the effect of subgingival injectable platelet-rich fibrin (i-PRF) application on clinical periodontal parameters as an adjunct to non-surgical periodontal treatment (NSPT) in smokers with periodontitis.
Twenty-five systemically healthy, smoker patients with stage II/III periodontitis were included in the study. In this split-mouth trial, subgingival i-PRF was applied to the test group in addition to NSPT, while saline was applied to the control group after NSPT. Subgingival i-PRF/saline application was repeated on the 7th day in both groups. Clinical periodontal parameters were recorded at baseline, 1st and 3rd months after the treatment.
Detailed description
Twenty-five systemically healthy, smoker patients with periodontitis were included in the study. All individuals were examined at baseline, 1st and 3rd months after non-surgical periodontal treatment including, whole mouth probing pocket depth (PPD), clinical attachment loss (CAL), presence of bleeding on probing (BOP), gingival index (GI) and Turesky Modified Quigley-Hein Plaque Index (TQHPI) except the third molars. PPD and CAL were measured at six sites per tooth using a manual periodontal probe. All measurements and NSPT were performed by the same blinded and calibrated examiner (TCG).
The NSPT included supra- and subgingival scaling, root planing and oral hygiene instructions. Subgingival scaling and root planing were performed under local anesthesia within the 24 h. After NSPT, four contralateral deep pockets (two for each side) in premolar/molar ares were determined. The sites were randomly divided into test sites receiving the subgingival application of i-PRF and controls treated with saline.
After the NSPT was completed, the i-PRF was produced as follows: 9 mL of whole blood was collected from the antecubital vein in a sterile plastic tubes without anticoagulant and immediately centrifuged at 700 rpm for 3 minutes with a centrifuge device. After centrifugation, the upper liquid layer was collected as i-PRF and placed into an insulin syringe connected to a 29G needle.
Before the i-PRF application, the teeth were isolated with a cotton roll and dried with a cotton pellet. The 29-gauge needle tip was gently placed into the periodontal pocket and the i-PRF was injected into the periodontal pocket until it reached the gingival margin (until it overflowed from the sulcus). For the subgingival saline application, the insulin syringe was filled with saline and the 29-gauge needle tip was gently placed into the periodontal pocket. The saline was injected into the periodontal pocket until it was seen to overflow from the gingival margin. After the subgingival application of i-PRF/saline , the application areas were isolated and waited for 10 minutes in order to prevent the i-PRF from being removed from the sulcus with oral fluids until it turned into a gel. Subgingival i-PRF/salin application was performed by a periodontist (BMY).Patients were instructed not to drink or eat anything, including water, for at least 30 minutes after the procedure. Patients were informed about oral hygiene practices (tooth brushing and interdental cleaning) and were motivated to perform daily oral care. Patients were given an appointment for the second application of i-PRF/salin application 7 days later. In this session, i-PRF/salin application was applied to the previously applied areas, oral hygiene was checked and patients were informed again. Patients were called again in the 1st and 3rd months, periodontal clinical measurements were repeated and oral hygiene motivation was given.
Statistical analyses were performed using a statistical analysis software (SPSS v.25.0; IBM). The Shapiro Wilk test was used to determine the normality of the present data and the variance homogeneity was checked with the Levene test. For non-normally distributed data, the Mann Whitney U test was used for pairwise comparison. The Independent Samples T test was performed for normally distributed data. The Friedman test was used to examine the differences between three dependent groups. Bonferroni correction was performed for multiple variations. The statistical significance value was accepted as p \< 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth, randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Procedure: Non-surgical periodontal treatment, Other: Subgingival application of i-PRFTest sites receiving the subgingival application of i-PRF after NSPT. |
| Control group | Placebo comparator | Procedure: Non-surgical periodontal treatment, Device: Subgingival application of salineControl sites treated with saline after NSPT. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients were systemically healthy adults,
- having at least 20 natural teeth,
- the presence of contralateral periodontal pockets (PPD≥ 5 mm) and CAL≥2 mm on a minimum of two premolar/molar teeth on each side and no furcation involvement,
- smoking more than 10 cigarettes per day for at least 5 years,
- stage II-III periodontitis patients
Key exclusion criteria (5 listed)
- individuals had past periodontal treatment within 6 months
- individuals had used systemic antibiotics in the last 6 months or anti- inflammatory drugs in the last 3 months before the beginning of the trial,
- patient with clotting and hematologic disorders, had used drugs affecting the natural coagulation process,
- patients taking medications that affect the gingival and periodontal tissues
- pregnant or breastfeeding females
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 |
|---|---|---|
| Non-surgical periodontal treatmentThe non-surgical periodontal treatment (scaling and root planing) was applied under local anesthesia using ultrasonic device and Gracey curettes. After scaling and root planing, periodontal pockets were irrigated using saline solution. Non-surgical periodontal treatment was completed in one or two sessions within 24 hours. | Procedure or surgery | Control group, Test group |
| Subgingival application of salineFor the subgingival saline application at the control sites, the insulin needle was filled with saline and the 29-gauge needle tip was gently placed into the periodontal pocket. The saline was injected into the periodontal pocket until it was seen to overflow from the gingival margin. Subgingival saline application was repeated on the 7th day. | Device | Control group |
| Subgingival application of i-PRFFor subgingival application of i-PRF at the test sites, the i-PRF taken into the insulin syringe, the 29-gauge needle tip was gently placed into the periodontal pocket and the i-PRF was injected into the periodontal pocket until it reached the gingival margin (until it overflowed from the sulcus). Subgingival i-PRF application was repeated on the 7th day. | Other | Test group |
Primary outcome
Clinical attachment loss (CAL)
Time frame: Baseline, 1st and 3rd months
CAL measured as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus (the most coronal attachment) using a Williams periodontal probe. The changes in clinical attachment loss was measured for determining the severity of disease.
Probing pocket depth (PPD)
Time frame: Baseline, 1st and 3rd months
PPD measured as the change in distance from the gingival margin to the bottom of the gingival sulcus using a Williams periodontal probe. The changes in PPD was measured for determining of the severity of disease and clinical outcome.
3 secondary outcomes
Bleeding on probing (BOP)
Time frame: Baseline, 1st and 3rd months
Turesky Modified Quigley-Hein Plaque Index (TQHPI)
Time frame: Baseline, 1st and 3rd months
Gingival index (GI)
Time frame: Baseline, 1st and 3rd months
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 Sep 2024.
- Derived from this study: PubMed 40269777Cagiran Gurbuz T, Meraci Yildiran B. The clinical efficacy of injectable platelet-rich fibrin (i-PRF) as an adjunct to nonsurgical periodontal therapy in smokers with periodontitis. BMC Oral Health. 2025 Apr 23;25(1):618. doi: 10.1186/s12903-025-06019-w.
- 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.
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 Non-surgical periodontal treatment, Subgingival application of saline and Subgingival application of i-PRF in people with Periodontitis, run by Abant Izzet Baysal University 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 5 inclusion and 5 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 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
Clinical attachment loss (CAL) (time frame: Baseline, 1st and 3rd months). 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?
On the ClinicalTrials.gov record for NCT06605547, which also lists 1 linked publication.
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 Sep 2024.