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

NCT ID: NCT07313254

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2025-05-20

Brief Summary

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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

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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

Conditions

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Periodontitis Periodontal Diseases

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Model Description
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking Description

Study Groups

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

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).

Group Type ACTIVE_COMPARATOR

OFD with zinc substituted nano HA combined with PRF block

Intervention Type 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 nano-hydroxyapatite graft using a full thickness mucoperiosteal flap

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

Group Type ACTIVE_COMPARATOR

OFD with zinc substituted nano HA

Intervention Type 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 a nano-hydroxyapatite graft using full thickness mucoperiosteal flap surgical techniq

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

Group Type ACTIVE_COMPARATOR

OFD with nano HA

Intervention Type 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).

Interventions

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OFD with zinc substituted nano HA combined with PRF block

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).

Intervention Type PROCEDURE

OFD with zinc substituted nano HA

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).

Intervention Type PROCEDURE

OFD with nano HA

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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Those who smoke.
2. Women who are pregnant.
3. Patients with poorly controlled systemic diseases which preclude local anesthesia or surgical procedures.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eman Yehia

Ismailia, Ismailia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 30166839 (View on PubMed)

Related Links

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https://pmc.ncbi.nlm.nih.gov/articles/PMC6104351/

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

Other Identifiers

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596/2022

Identifier Type: -

Identifier Source: org_study_id