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Clinical Trials/NCT07313254
NCT07313254CompletedNot Applicable

Clinical And Radiographic Evaluation Of Zinc Substituted Nanohyrdoxyappatite Bone Graft And Advanced Platelet Rich Fibrin Block In The Treatment Of Periodontal Intrabony Defects: A Randomized Controlled Study

Suez Canal University2 sites in 1 country30 target enrollmentStarted: January 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
measurement of gingival indices

Study Overview

Brief Summary

Periodontal intrabony defects pose a significant challenge in clinical dentistry due to their complex anatomy and limited regenerative potential. Recent advancements in biomaterials and regenerative techniques have introduced novel approaches to enhance periodontal healing. This study evaluates the clinical and radiographic outcomes of using nano-hydroxyapatite (nHA) and zinc-substituted nano-hydroxyapatite (Zn-nHA) in combination with advanced platelet-rich fibrin (A-PRF) blocks for the treatment of periodontal intrabony defects.

Nano-hydroxyapatite, a biomimetic material, has shown promise in promoting bone regeneration due to its osteoconductive properties. Zinc substitution further enhances its biological activity by incorporating antimicrobial and osteoinductive characteristics. Advanced PRF, a second-generation platelet concentrate, provides a scaffold rich in growth factors and cytokines, which synergistically supports tissue regeneration.

Detailed Description

Periodontitis causes deep periodontal pockets due to bone and attachment loss. Zinc-substituted hydroxyapatite enhances bone regeneration, while PRF promotes healing through growth factors. Their combination as a PRF block offers a promising approach for periodontal defect repair. This randomized controlled clinical trial was conducted to compare the effectiveness of zinc-substituted nano-hydroxyapatite alone and in combination with platelet-rich fibrin (PRF) block in the treatment of intrabony periodontal defects. Thirty patients diagnosed with periodontitis were selected based on defined inclusion and exclusion criteria and were randomly allocated into three equal groups. Each group received a different grafting material using a full-thickness mucoperiosteal flap surgical technique. Standardized clinical parameters-including gingival index, plaque index, probing pocket depth, and clinical attachment level-were recorded at baseline and six months post-operatively. Radiographic assessments were also performed to evaluate bone changes using digital imaging and image analysis software. The zinc-substituted grafts were prepared using a chemical process, and PRF blocks were created by combining advanced and injectable PRF with the graft material

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Masking Description

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adequate oral hygiene conditions.
  • Age range from 20 years to 50 years.
  • All patients will be physically healthy.
  • Patients who are co-operatively motivated.

Exclusion Criteria

  • Those who smoke.
  • Women who are pregnant.
  • Patients with poorly controlled systemic diseases which preclude local anesthesia or surgical procedures.

Outcomes

Primary Outcomes

measurement of gingival indices

Time Frame: From enrollment to the end of treatment at 6 months

Gingival index (Loe et al.,1963): Score Criteria: 0- No inflammation. 1. Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation, moderate glazing, redness, bleeding on probing. 3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.

measurement of plaque indices

Time Frame: 6 monthes

• Plaque index (Silness et al.,1964): We determine the amount of plaque on the tooth surface using a scale from 0 to 3: 0- No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which could not be seen with the naked eye. But only by using disclosing solutions or by using probe. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which could be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

measurement of probing pocket depth

Time Frame: 6 months

Probing pocket depth : Probing pocket depth (PD) is measured by using William's graduated probe from the free gingival margin to the base of the periodontal pocket.

Measurement of Clinical attachment level

Time Frame: 6 months

The clinical attachment level (CAL) is measured by using periodontal probe from the cemento - enamel junction to the bottom of the pocket at each selected site.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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