Periodontal PocketPhase 2NCT06570200
Evaluation of iPRF With Vit.D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis
A Phase 2 study testing PMPR+iPRF, PMPR+iPRF+Vit.D and PMPR only in people with Periodontal Pocket, run by Cairo University.
Trial summary
a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- PMPR+iPRF, PMPR+iPRF+Vit.D and PMPR only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Feb 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- Patients with Stage III periodontitis.
- Patients accept 3-month follow-up period (cooperative patients).
- Patients provide an informed consent.
Who cannot join
- Presence of prosthetic crowns.
- Extensive interproximal restorations.
- Periodontal therapy within the last 12 months.
- Having undergone surgical periodontal therapy or undergoing orthodontic treatment.
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- The use of antibiotics or anti-inflammatory drugs 3-month prior to the procedure and till the end of 6-month of follow-up.
- Smokers.
- Pregnant females.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Injectable PRF With Vitamin D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis. A Randomized Controlled Clinical Trial
a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients
Read the detailed description
in this clinical trial, the treatment of periodontal pockets in stage III periodontitis patients will be evaluated. the study participants will be divided in 3 groups:
First group >> will be treated with professional mechanical plaque removal (PMPR) only.
second group >> will be treated with PMPR + locally applied iPRF.
Third group >> will be treated with PMPR + locally applied iPRF + vitamin D.
Then the results will be compared after 6 months of the treatment (clinically and radiographically).
- Conditions
- Periodontal Pocket
- Being tested
- PMPR+iPRF, PMPR+iPRF+Vit.D, PMPR only
- Keywords
- iPRF, vitamin D, Cholecalciferol, periodontal pocket
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMPR+iPRFProcedure or surgery
Also called scaling plus locally applied iPRF
locally applied iPRF in the periodontal pocket
PMPR+iPRF+Vit.DDrug
Also called scaling plus locally applied iPRF nd vitamin D
locally applied iPRF plus vitamin D in the periodontal pocket
PMPR onlyProcedure or surgery
Also called scaling only
scaling and root planing only will be done for the periodontal pocket for the control group
| Study group | Role | What they receive |
|---|---|---|
| PMPR only | Active comparator | scaling and root planing only will be made for group 1 (control group) Receives: Procedure: PMPR only |
| PMPR + iPRF | Experimental | scaling and root planing plus locally applied iPRF in the periodontal pocket will be made for test group 1. Receives: Procedure: PMPR+iPRF |
| PMPR + iPRF + Vit.D | Experimental | scaling and root planing plus locally applied iPRF and vitamin D in the periodontal pocket will be made for test group 2.
vitamin D will be obtained from a commercial product in the Egyptian pharmacies called (Devarol S) in the form of injectable ampoules containing 200000 IU of cholecalciferol (2.5 mg/ml) Receives: Drug: PMPR+iPRF+Vit.D |
What is being measured
The primary outcome is the main question the study is designed to answer.
pocket depth reduction
estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment
Measured: 6 months
Secondary outcomes (7)
clinical attachment level (CAL) gain
the amount of CAL gained from baseline and after 6 months of treatment
Measured: 6 months
Plaque index
comparison of amount of plaque before and after treatment using plaque score
Measured: 6 months
Bleeding on probing (BOP)
measuring the percentage of BOP using a periodontal probe before and after treatment
Measured: 6 months
Gingival Marginal Level (GML)
determining the location of gingival margin in relation to the tooth before and after treatment
Measured: 6 months
Post-operative Pain
comparing the pain before and after treatment using Visual Analogue Scale(VAS) Questionnaire. A scale from 0-10 will be used with 0 means no pain and 10 means maximum pain.
Measured: 6 months
Treatment time taken for each groups
a timer will be used to determine the required time of each procedure of the 3 study groups
Measured: 6 months
degree of bone fill or loss
using digital software, evaluation of the radiographic changes will be done at the area diagnosed with periodontal problem and selected for the treatment before and after the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (estimated)
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 Periodontal PocketStudies of the same condition, open and under way.
- More trials run by Cairo 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed hamed fattouh hamed, Cairo University
- Investigators
- Prof.Dr Manal Hosny, professor, Study director, Cairo UniversityProf.Dr Karim Fawzy, Professor, Study director, Cairo UniversityProf.Dr Luigi Nibali, Professor, Study director, King's College LondonDr.Manar T El-zanaty, Doctorate, Study director, Cairo UniversityAhmed Fattouh, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570200
- Sponsor's protocol ID
- CairoU50022
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8.
PubMed 38153510
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Injectable PRF With Vitamin D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06570200
- Acronym / sponsor ID
- CairoU50022
- Conditions
- Periodontal Pocket
- Keywords
- iPRF, vitamin D, Cholecalciferol, periodontal pocket
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 26 Aug 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.
a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients
Detailed description
in this clinical trial, the treatment of periodontal pockets in stage III periodontitis patients will be evaluated. the study participants will be divided in 3 groups:
First group >> will be treated with professional mechanical plaque removal (PMPR) only.
second group >> will be treated with PMPR + locally applied iPRF.
Third group >> will be treated with PMPR + locally applied iPRF + vitamin D.
Then the results will be compared after 6 months of the treatment (clinically and radiographically).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PMPR only | Active comparator | Procedure: PMPR onlyscaling and root planing only will be made for group 1 (control group) |
| PMPR + iPRF | Experimental | Procedure: PMPR+iPRFscaling and root planing plus locally applied iPRF in the periodontal pocket will be made for test group 1. |
| PMPR + iPRF + Vit.D | Experimental | Drug: PMPR+iPRF+Vit.Dscaling and root planing plus locally applied iPRF and vitamin D in the periodontal pocket will be made for test group 2. vitamin D will be obtained from a commercial product in the Egyptian pharmacies called (Devarol S) in the form of injectable ampoules containing 200000 IU of cholecalciferol (2.5 mg/ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- Patients with Stage III periodontitis.
- Patients accept 3-month follow-up period (cooperative patients).
- Patients provide an informed consent.
Key exclusion criteria (8 listed)
- Presence of prosthetic crowns.
- Extensive interproximal restorations.
- Periodontal therapy within the last 12 months.
- Having undergone surgical periodontal therapy or undergoing orthodontic treatment.
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
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 |
|---|---|---|
| PMPR+iPRFAlso: scaling plus locally applied iPRFlocally applied iPRF in the periodontal pocket | Procedure or surgery | PMPR + iPRF |
| PMPR+iPRF+Vit.DAlso: scaling plus locally applied iPRF nd vitamin Dlocally applied iPRF plus vitamin D in the periodontal pocket | Drug | PMPR + iPRF + Vit.D |
| PMPR onlyAlso: scaling onlyscaling and root planing only will be done for the periodontal pocket for the control group | Procedure or surgery | PMPR only |
Primary outcome
pocket depth reduction
Time frame: 6 months
estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment
7 secondary outcomes
clinical attachment level (CAL) gain
Time frame: 6 months
Plaque index
Time frame: 6 months
Bleeding on probing (BOP)
Time frame: 6 months
Gingival Marginal Level (GML)
Time frame: 6 months
Post-operative Pain
Time frame: 6 months
Treatment time taken for each groups
Time frame: 6 months
degree of bone fill or loss
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 38153510Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8.
- Individual participant dataSharing planned: No
Related trials for Periodontal Pocket
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Not yet recruitingPhase 2
Effect of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defect
Infra-bony Periodontal Defect
Not yet recruiting
Diode Laser 635 nm and 810 nm Photodynamic Therapy as Adjuncts to Non-Surgical Periodontal Treatment
Periodontitis
Not yet recruiting
Clinical Effectiveness of Oxygen-Releasing Oral Gel as an Adjunct to Scaling and Root Debridement in Patients With Severe Periodontal Pockets: A Randomized Clinical Trial
Periodontitis
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.
Prof.Dr Manal Hosny, professor study director
Cairo University
Prof.Dr Karim Fawzy, Professor study director
Cairo University
Prof.Dr Luigi Nibali, Professor study director
King's College London
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PMPR+iPRF, PMPR+iPRF+Vit.D and PMPR only in people with Periodontal Pocket, run by Cairo University.
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 8 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 26 Aug 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ahmed Fattouh, Bachelor (+201015013868, ahmed.fattouh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pocket depth reduction (time frame: 6 months). 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 NCT06570200, 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 26 Aug 2024.