Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects

NCT06347263 | Recruiting

• 1 other identifier: PER 332
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis.

Conditions

Isolated Intrabony Periodontal Defects in Patients With Periodontitis

Keywords

Periodontal intrabony defects; Entire papilla preservation technique; EPPT; Injectable platelet rich fibrin; I-PRF

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL) gain change from baseline to 12 months

  The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements.

  CAL gain will be taken at baseline, 3 month, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner.]

Secondary Outcomes (1)

• Linear bone fill change from baseline to 12 months

  Linear bone fill will be measured at baseline, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner]

Study Arms (2)

Test group

EXPERIMENTAL

Procedure:Entire papilla preservation technique with autogenous bone and injectable platelet rich fibrin

Other: Entire papilla preservation technique

Control group

ACTIVE COMPARATOR

Procedure: Entire papilla preservation technique alone.

Other: Entire papilla preservation technique

Interventions

Entire papilla preservation technique OTHER

Minimally invasive periodontal surgery

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with healthy systemic condition.
• Adult patients (18 years old and older).
• Patients with stage lll periodontitis, having one isolated intrabony defect with probing depth \>6mm, clinical attachment level\> 6mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth.
• Patients with full mouth plaque score\<20%.
• Patients with full mouth bleeding score\<20%.
• Compliance with good oral hygiene.
• Patients accept 6-months follow-up period (cooperative patients).
• Patients provide an informed consent.

You may not qualify if:

• Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
• One wall intrabony defect.
• Defects that involve the buccal and lingual sites.
• Smokers ˃ 10 cigarettes / day.
• Pregnant and lactating females.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, 3753450, Egypt

RECRUITING

Study Officials

• Laila T Sedeek, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Manal M Hosny, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Laila T Sedeek, Bachelor

CONTACT

01223685495; laila.taher@dentistry.cu.edu.eg

Nesma M Shemais, Ass Lecturer

CONTACT

nesma.shemais@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the operator and patient is not applicable. \- Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 12, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 30, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

EG (1)