CHRONIC PERIODONTITISNCT04070729
Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy
A study testing Hyaluronic acid gel and Platelet rich fibrin in people with CHRONIC PERIODONTITIS, run by Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.
Trial summary
Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid. 120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CHRONIC PERIODONTITIS
- What is being tested?
- Hyaluronic acid gel and Platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2019to 25 Jan 2020
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are in general good health.
- Patients having minimum of 20 permanent teeth.
- They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
- Presence of periodontal pockets (≥5 mm) and clinicala ttachment level > 5 mm.
Who cannot join
- Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
- Clotting and Hematological disorders
- Patients with grade III mobility.
- Patients with smoking and alcohol consuming habit.
- Pregnant and lactating female.
- Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)
- The teeth with poor filling and ill fitted restorations
About this study
Official title: Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial
Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.
120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.
Read the detailed description
The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.
- Conditions
- CHRONIC PERIODONTITIS
- Being tested
- Placebo gel, Hyaluronic acid gel, Platelet rich fibrin
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelOther
Also called Cellulose gel
Localized subgingival application
Hyaluronic acid gelDrug
Localized subgingival application
Platelet rich fibrinBiological
Localized subgingival application
| Study group | Role | What they receive |
|---|---|---|
| Negative control | Placebo comparator | Placebo gel Receives: Other: Placebo gel |
| Test group 1 | Experimental | Hyaluronic acid gel Receives: Drug: Hyaluronic acid gel |
| Test group 2 | Experimental | injectable prf Receives: Biological: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
Measured: 3 Months
Secondary outcomes (1)
Probing pocket depth
Measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start28 Aug 2019 (estimated)
- Primary completion28 Nov 2019 (estimated)
- Study completion25 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHRONIC PERIODONTITISStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASHISH AGARWAL, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070729
- Sponsor's protocol ID
- IEC/IDS50/2019
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04070729
- Acronym / sponsor ID
- IEC/IDS50/2019
- Conditions
- CHRONIC PERIODONTITIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute of Dental Sciences, Bareilly, Uttar Pradesh, IndiaUniversity, hospital or other
- Study start
- 28 Aug 2019 (estimated)
- Primary completion
- 28 Nov 2019 (estimated)
- Study completion
- 25 Jan 2020 (estimated)
- First posted
- 28 Aug 2019 (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.
Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.
120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.
Detailed description
The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative control | Placebo comparator | Other: Placebo gelPlacebo gel |
| Test group 1 | Experimental | Drug: Hyaluronic acid gelHyaluronic acid gel |
| Test group 2 | Experimental | Biological: Platelet rich fibrininjectable prf |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are in general good health.
- Patients having minimum of 20 permanent teeth.
- They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
- Presence of periodontal pockets (≥5 mm) and clinicala ttachment level > 5 mm.
Key exclusion criteria (7 listed)
- Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
- Clotting and Hematological disorders
- Patients with grade III mobility.
- Patients with smoking and alcohol consuming habit.
- Pregnant and lactating female.
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 |
|---|---|---|
| Placebo gelAlso: Cellulose gelLocalized subgingival application | Other | Negative control |
| Hyaluronic acid gelLocalized subgingival application | Drug | Test group 1 |
| Platelet rich fibrinLocalized subgingival application | Biological | Test group 2 |
Primary outcome
Clinical attachment level (CAL)
Time frame: 3 Months
Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
1 secondary outcome
Probing pocket depth
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid gel and Platelet rich fibrin in people with CHRONIC PERIODONTITIS, run by Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 level (CAL) (time frame: 3 Months). 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 28 Aug 2019.