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

NCT07313254 | Completed DMC

• 1 other identifier: 596/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Periodontal Diseases

Keywords

nano-hydroxyapatite; advanced platelet-rich fibrin blocks; zinc-substituted nano-hydroxyapatite

Outcome Measures

Primary Outcomes (4)

• measurement of gingival indices

  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.

  From enrollment to the end of treatment at 6 months

• measurement of plaque indices

  • 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.

  6 monthes

• measurement of probing pocket depth

  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.

  6 months

• Measurement of Clinical attachment level

  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.

  6 months

Study Arms (3)

treating with zinc substituted hydroxyapatite graft combined with PRF block using full flap

ACTIVE COMPARATOR

patients were treated with zinc substituted hydroxyapatite graft combined with platelet rich fibrin block using a full thickness mucoperiosteal flap surgical technique. After the pretreatment phase, patients were recalled under local anesthesia an intrasulcular incision was 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).

Procedure: OFD with zinc substituted nano HA combined with PRF block

treating with zinc substituted nano-hydroxyapatite graft using a full thickness mucoperiosteal flap

ACTIVE COMPARATOR

patients were treated with zinc substituted nano-hydroxyapatite graft using a full thickness mucoperiosteal flap surgical technique.

Procedure: OFD with zinc substituted nano HA

treating with a nano-hydroxyapatite graft using full thickness mucoperiosteal flap surgical techniq

ACTIVE COMPARATOR

patients were treated with a nano-hydroxyapatite graft using a full thickness mucoperiosteal flap surgical technique.

Procedure: OFD with nano HA

Interventions

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).

treating with zinc substituted hydroxyapatite graft combined with PRF block using full flap

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).

treating with zinc substituted nano-hydroxyapatite graft using a full thickness mucoperiosteal flap

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).

treating with a nano-hydroxyapatite graft using full thickness mucoperiosteal flap surgical techniq

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Eman Yehia

Ismailia, Ismailia Governorate, 54321, Egypt

Location

Related Publications (1)

• Bhardwaj VA, Deepika PC, Basavarajaiah S. Zinc Incorporated Nano Hydroxyapatite: A Novel Bone Graft Used for Regeneration of Intrabony Defects. Contemp Clin Dent. 2018 Jul-Sep;9(3):427-433. doi: 10.4103/ccd.ccd_192_18.

  PMID: 30166839 RESULT

Related Links

• Zinc Incorporated Nano Hydroxyapatite: A Novel Bone Graft Used for Regeneration of Intrabony Defects

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: December 31, 2025
• Study Start: January 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: May 20, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

EG (1)