Investigating the Role of Nano-Hydroxyapatite and Self-Assembling Peptide in the Prevention and Treatment of Carbonated Water-Induced Erosion in Primary Teeth

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260308068973N1

Enrollment

Registered

2026-05-02

Start date

2026-05-22

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Dental erosion. Erosion of teeth

Interventions

Intervention 1: Negative control group: Specimens are immersed in sterile artificial saliva for 1 minute, then rinsed with distilled water. Intervention 2: Positive control group: Neutral sodium fluor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Extracted primary (deciduous) teeth (maxillary or mandibular, anterior or posterior) without any clinical signs of caries or erosion. Absence of caries, enamel hypoplasia, cracks, attrition, or visible erosive lesions. Intact buccal enamel surface. No structural defects or any other type of enamel defect.

Exclusion criteria

Exclusion criteria: Presence of caries, cracks, hypoplasia, fluorosis, or erosive lesions on the tooth surface. Teeth with any restoration on the surface to be examined. Presence of any developmental or structural anomalies of enamel. Teeth damaged during preparation (e.g., cutting or embedding procedures). Samples showing severe discoloration or structural breakdown during the experimental process (remineralization or re-demineralization steps).

Design outcomes

Primary

Measure	Time frame
Changes in superficial microhardness of primary tooth enamel. Timepoint: Four time points: T1 (baseline), T2 (after initial demineralization), T3 (after intervention application), T4 (after re-demineralization). Method of measurement: Vickers microhardness test using a digital hardness tester (Zwick/Roell ZHV.U/K) with a load of 50 grams applied for 15 seconds. Three points are measured per specimen, and the average value is recorded as Vickers Hardness Number (VHN).;Changes in surface topography of primary tooth enamel. Timepoint: After final re-demineralization stage (at the end of the experiment). Method of measurement: Scanning electron microscopy (SEM). Two randomly selected specimens from each group are examined. Surface parameters including average roughness (Ra) and mean roughness depth (Rz) are analyzed using ImageJ software.	—

Measure

Time frame

Changes in superficial microhardness of primary tooth enamel. Timepoint: Four time points: T1 (baseline), T2 (after initial demineralization), T3 (after intervention application), T4 (after re-demineralization). Method of measurement: Vickers microhardness test using a digital hardness tester (Zwick/Roell ZHV.U/K) with a load of 50 grams applied for 15 seconds. Three points are measured per specimen, and the average value is recorded as Vickers Hardness Number (VHN).;Changes in surface topography of primary tooth enamel. Timepoint: After final re-demineralization stage (at the end of the experiment). Method of measurement: Scanning electron microscopy (SEM). Two randomly selected specimens from each group are examined. Surface parameters including average roughness (Ra) and mean roughness depth (Rz) are analyzed using ImageJ software.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoza Haghgoo

Shahed University

r.haghgoo@shahed.ac.ir+98 21 5121 2000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026