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NCT Number: NCT06297577

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

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.

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Key information

Conditions

Intrabony Periodontal Defect Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Ability to sign an informed consent form.
  • Patients age ≥18 years old.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index.

Exclusion criteria

  • Patient undergoing orthodontic treatment.
  • Pregnant females or breast feeding.
  • Smokers.
  • Teeth mobility greater than grade I.

Treatment and study plan

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

Procedure

Albumin-PRF will be placed into intrabony defect

Minimally invasive surgical technique (MIST)

Procedure

MIST will be the surgical access for treatment of Intrabony defect

Primary outcomes

  1. Clinical attachment level (CAL)

    Time frame: 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 outcomes

  1. Probing Depth (PD)

    Time frame: 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.

  2. Radiographic Linear Defect Depth (RLDD)

    Time frame: 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)

  3. Recession Depth (RD)

    Time frame: 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.

  4. Post-operative Pain

    Time frame: During first week postoperative

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

  5. Radiographic defect fill (RDF)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Manal Hosny, Professor

CONTACT

[email protected]

Mashaal Mohammed, Master

CONTACT

[email protected]

00201094483995

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin (Alb-PRF) Versus Minimally Invasive Surgical Technique (MIST) in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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