- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07313254
Clinical And Radiographic Evaluation Of Zinc Substituted Nanohyrdoxyappatite Bone Graft And Advanced Platelet Rich Fibrin Block In The Treatment Of Periodontal Intrabony Defects (R C S)
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ismailia Governorate
-
Ismailia, Ismailia Governorate, Egypt, 54321
- Eman Yehia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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). |
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).
|
|
Active Comparator: 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.
|
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).
|
|
Active Comparator: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment at 6 months
|
|
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
|
6 monthes
|
|
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. |
6 months
|
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 596/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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