An ultrasound study to see how natural nano hydroxyapatite powder helps bone healing in patients after root canal surgery

Assessing the effectiveness of novel fish scale nanohydroxy appatite (FSHA) in bone healing post endodontic surgery-An ultrasonographic randomized controlled study - nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099237

Enrollment

Registered

2025-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fish Scale Derived Nanohydroxyapatite(FSHA): A pre-sterilized, fish scale derived nano-hydroxyapatite (F-SHA) biomaterial will be applied into the bony defect following endodontic surge

Eligibility

Inclusion criteria

Inclusion criteria: requiring periapical/endodontic surgery for management of a persistent periapical lesion.

Exclusion criteria

Exclusion criteria: Patients with uncontrolled diabetes, systemic illnesses that impair healing, immunocompromised conditions, bleeding disorders, active infections, allergy to graft materials, or those unable to maintain oral hygiene will be excluded. Pregnant or lactating women, patients with prior head-and-neck radiotherapy, and individuals unwilling to provide consent or attend follow-up visits will also not be included in the study.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the percentage of bone fill (%) in the periapical defect, assessed using ultrasonography. Healing will be evaluated at baseline, followed by 1 month, 3 months, and 6 months post-surgery, with the 6-month assessment serving as the primary endpoint for comparison between groups.Timepoint: The primary outcome of the study is the percentage of bone fill (%) in the periapical defect, assessed using ultrasonography. Healing will be evaluated at baseline, followed by 1 month, 3 months, and 6 months post-surgery, with the 6-month assessment serving as the primary endpoint for comparison between groups.	—

Measure

Time frame

The primary outcome of the study is the percentage of bone fill (%) in the periapical defect, assessed using ultrasonography. Healing will be evaluated at baseline, followed by 1 month, 3 months, and 6 months post-surgery, with the 6-month assessment serving as the primary endpoint for comparison between groups.Timepoint: The primary outcome of the study is the percentage of bone fill (%) in the periapical defect, assessed using ultrasonography. Healing will be evaluated at baseline, followed by 1 month, 3 months, and 6 months post-surgery, with the 6-month assessment serving as the primary endpoint for comparison between groups.

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Secondary

Measure	Time frame
Secondary outcomes will assess the long-term stability of bone healing, including bone density changes, maintenance of bone fill, vascularity patterns on ultrasonography, and overall clinical success (absence of symptoms, sinus tract, or need for re-intervention). Patient-reported outcomes such as postoperative pain and functional recovery will also be evaluated.Timepoint: Secondary outcomes will be assessed at 12 months, 24 months, and 36 months (3 years) after surgery to evaluate the durability, stability, and clinical effectiveness of bone regeneration achieved with F-SHA compared to c-HA.	—

Measure

Time frame

Secondary outcomes will assess the long-term stability of bone healing, including bone density changes, maintenance of bone fill, vascularity patterns on ultrasonography, and overall clinical success (absence of symptoms, sinus tract, or need for re-intervention). Patient-reported outcomes such as postoperative pain and functional recovery will also be evaluated.Timepoint: Secondary outcomes will be assessed at 12 months, 24 months, and 36 months (3 years) after surgery to evaluate the durability, stability, and clinical effectiveness of bone regeneration achieved with F-SHA compared to c-HA.

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Countries

India

Contacts

Public ContactDr Promila Verma

King Georges Medical University

promilaverma@kgmcindia.edu9415542063

Outcome results