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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Vital teeth.

No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.

No periodontal therapy carried out in the past 6 months.

Disqualifiers

Patient undergoing orthodontic treatment.

Pregnant females or breast feeding.

Smokers.

Teeth mobility greater than grade I.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)

    Procedure/Surgery

    Albumin-PRF will be placed into intrabony defect

  • Minimally invasive surgical technique (MIST)

    Procedure/Surgery

    MIST will be the surgical access for treatment of Intrabony defect

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Albumin Platelet Rich Fibrin (Alb-PRF)Experimental treatment 1 intervention
Group B: Minimally Invasive Surgical Technique (MIST)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

Post-operative Pain

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

Time frame
During first week postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: