Clinical trial NCT06570200: Evaluation of iPRF With Vit.D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Periodontal Pocket
Keywords: iPRF
vitamin D
Cholecalciferol
periodontal pocket
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: Inclusion Criteria:

1. Patients with healthy systemic condition.
2. Adult patients ˃ 18 years old.
3. Patients with Stage III periodontitis.
4. Patients accept 3-month follow-up period (cooperative patients).
5. Patients provide an informed consent.

Exclusion Criteria:

1. Presence of prosthetic crowns.
2. Extensive interproximal restorations.
3. Periodontal therapy within the last 12 months.
4. Having undergone surgical periodontal therapy or undergoing orthodontic treatment.
5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
6. The use of antibiotics or anti-inflammatory drugs 3-month prior to the procedure and till the end of 6-month of follow-up.
7. Smokers.
8. Pregnant females.

Primary outcomes:
measure: pocket depth reduction
timeFrame: 6 months
Secondary outcomes:
measure: clinical attachment level (CAL) gain
timeFrame: 6 months
measure: Plaque index
timeFrame: 6 months
measure: Bleeding on probing (BOP)
timeFrame: 6 months
measure: Gingival Marginal Level (GML)
timeFrame: 6 months
measure: Post-operative Pain
timeFrame: 6 months
measure: Treatment time taken for each groups
timeFrame: 6 months
measure: degree of bone fill or loss
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Prof.Dr Manal Hosny, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Prof.Dr Karim Fawzy, Professor
role: STUDY_DIRECTOR
affiliation: King's College London
name: Prof.Dr Luigi Nibali, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Dr.Manar T El-zanaty, Doctorate
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ahmed Fattouh, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.