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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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 groups in NCT06605547
Study groupRoleWhat they receive
Test groupActive comparatorTest sites receiving the subgingival application of i-PRF after NSPT.
Receives: Procedure: Non-surgical periodontal treatment; Other: Subgingival application of i-PRF
Control groupPlacebo comparatorControl 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted20 Sep 2024
  2. Study start4 Sep 2023
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

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)
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

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.

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