Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients

Not Applicable

Not yet recruiting

• Conditions: Intrabony Periodontal Defect

• Registration Number: NCT06297577
• Lead Sponsor: Cairo University

Brief Summary

Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.

The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:

will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Start: 2024-08-30
• Primary Completion: 2025-08-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area.
2. Vital teeth.
3. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
4. No periodontal therapy carried out in the past 6 months.
5. Ability to sign an informed consent form.
6. Patients age ≥18 years old.
7. Patients who are cooperative, motivated, and hygiene conscious.
8. Systemically free according to Cornell Medical Index.

Exclusion Criteria

1. Patient undergoing orthodontic treatment.
2. Pregnant females or breast feeding.
3. Smokers.
4. Teeth mobility greater than grade I.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	CAL will be measured at base line, 6, and 9 months postoperative	CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.

Secondary Outcome Measures

Name	Time	Method
Probing Depth (PD)	CAL will be measured at base line, 6, and 9 months postoperative	PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.
Radiographic Linear Defect Depth (RLDD)	Radiographic defect fill will be measured at base line, 6, and 9 months postoperative	Individually customized bite blocks will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. Periapical radiograph PSP sensor size two and standardized exposure setting of 60 kVp, 8 mA, 0.7 mm, and 0.10 s will be used. RLDD will be measured as the depth of the intrabony defect from the alveolar crest (AC) to the defect base (DB)
Recession Depth (RD)	RD will be measured at base line, 6, and 9 months postoperative	RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth.
Post-operative Pain	During first week postoperative	The visual analogue scale (VAS) score (0-10)
Radiographic defect fill (RDF)	Radiographic defect fill will be measured at base line, 6, and 9 months postoperative	Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values