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

N/ANot Yet RecruitingNCT06297577

Cairo University32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intrabony Periodontal Defect

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical attachment level (CAL)

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.

Time frame: CAL will be measured at base line, 6, and 9 months postoperative

Secondary Outcomes

Probing Depth (PD)

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.

Time frame: CAL will be measured at base line, 6, and 9 months postoperative

Radiographic Linear Defect Depth (RLDD)

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)

Time frame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative

Recession Depth (RD)

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.

Time frame: RD will be measured at base line, 6, and 9 months postoperative

Post-operative Pain

The visual analogue scale (VAS) score (0-10)

Time frame: During first week postoperative

Radiographic defect fill (RDF)

Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values

Time frame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative

Central Contacts

Mashaal Mohammed, Master

CONTACT

00201094483995 mashaal.abdullah@dentistry.cu.edu.eg

Manal Hosny, Professor

CONTACT

manhosny@gmail.com