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Completed

NCT Number: NCT07313254

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eman Yehia

Ismailia, Ismailia Governorate, 54321, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

OFD with zinc substituted nano HA combined with PRF block

Procedure

After the pretreatment phase, patients were recalled under local anesthesia an intrasulcular incision will performed with #15 blade elevating a full-thickness mucoperiosteal flap and after removing all the inflammatory granulation tissue we put in the defect Zinc substituted nano-hydroxyapatite graft combined in platelet-rich fibrin block (A-PRF +I-PRF+graft ). Zinc substituted nano hydroxyapatite graft was taken in a bone well, to which i-PRF was mixed and the cut pieces of the A-PRF membrane were incorporated. The resulted cohesive, packable graft "PRF block" which were placed into the defect. Then the mucoperiosteal flap returned to its position in both groups and sutured using silk suture size (4/0).

OFD with zinc substituted nano HA

Procedure

After the pretreatment phase, patients were recalled under local anesthesia an intrasulcular incision will performed with #15 blade elevating a full-thickness mucoperiosteal flap and after removing all the inflammatory granulation tissue we put in the defect Zinc substituted nano-hydroxyapatite graft. Then the mucoperiosteal flap returned to its position in both groups and sutured using silk suture size (4/0).

OFD with nano HA

Procedure

After the pretreatment phase, patients were recalled under local anesthesia an intrasulcular incision will performed with #15 blade elevating a full-thickness mucoperiosteal flap and after removing all the inflammatory granulation tissue we put in the defect nano-hydroxyapatite graft Then the mucoperiosteal flap returned to its position in both groups and sutured using silk suture size (4/0).

Primary outcomes

  1. 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.

    • Mild inflammation, slight change in color, slight edema, no bleeding on probing.
    • Moderate inflammation, moderate glazing, redness, bleeding on probing.
    • Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.

  2. 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

    • 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.
    • 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.
    • Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Acronym: R C S

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

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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