Evaluation of iPRF With Vit.D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis

NCT06570200 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CairoU50022
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Periodontal Pocket

Keywords

iPRF; vitamin D; Cholecalciferol; periodontal pocket

Outcome Measures

Primary Outcomes (1)

• pocket depth reduction

  estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment

  6 months

Secondary Outcomes (7)

• clinical attachment level (CAL) gain

  6 months

• Plaque index

  6 months

• Bleeding on probing (BOP)

  6 months

• Gingival Marginal Level (GML)

  6 months

• Post-operative Pain

  6 months

Study Arms (3)

PMPR only

ACTIVE COMPARATOR

scaling and root planing only will be made for group 1 (control group)

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.

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)

Drug: PMPR+iPRF+Vit.D

Interventions

PMPR+iPRF PROCEDURE

locally applied iPRF in the periodontal pocket

Also known as: scaling plus locally applied iPRF

PMPR + iPRF

PMPR+iPRF+Vit.D DRUG

locally applied iPRF plus vitamin D in the periodontal pocket

Also known as: scaling plus locally applied iPRF nd vitamin D

PMPR + iPRF + Vit.D

PMPR only PROCEDURE

scaling and root planing only will be done for the periodontal pocket for the control group

Also known as: scaling only

PMPR only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 38153510 BACKGROUND

MeSH Terms

Conditions

Periodontal Pocket

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Prof.Dr Manal Hosny, professor

  Cairo University

  STUDY DIRECTOR

• Prof.Dr Karim Fawzy, Professor

  Cairo University

  STUDY DIRECTOR

• Prof.Dr Luigi Nibali, Professor

  King's College London

  STUDY DIRECTOR

• Dr.Manar T El-zanaty, Doctorate

  Cairo University

  STUDY DIRECTOR

• Ahmed Fattouh, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Fattouh, Bachelor

CONTACT

+201015013868; ahmed.fattouh@dentistry.cu.edu.eg

Prof.Dr Karim Fawzy, professor

CONTACT

+201005444050; karim.fawzy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the masking will be applied in the two test groups where iPRF will be used and neither the principle investigator nor the participants will know if vitamin D will be applied to the iPrf or a placebo.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share