Evaluation of EQUIA Forte® HT as a restorative material for primary molars

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15852623

Enrollment

100

Registered

2023-08-21

Start date

2022-09-01

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Restoring carious primary teeth in children Oral Health

Interventions

Study design: This study will be a randomized clinical trial (double-blinded to participants and evaluator), following the CONSORT guidelines. The study will be conducted at the Dental University Hosp

Clinically: 1. Restorable primary molars with one proximal carious lesions (code 4 or 5 proximal carious lesions according to ICDAS II) 2. No signs of pulpal involvement (spontaneous or persistent pai

Eligibility

Sex/Gender

All

Age

4 Years to 11 Years

Inclusion criteria

Inclusion criteria: Clinical participant inclusion criteria: 1. Restorable primary molars with one proximal carious lesion (code 4 or 5 proximal carious lesions according to ICDAS II) 2. No signs of pulpal involvement (spontaneous or persistent pain, pathological mobility, tenderness to percussion) 3. Have a good likelihood of recall availability Radiographic participant inclusion criteria: 1. Proximal radiolucency in the outer half of the dentin 2. No more than two-thirds of physiologic root resorption 3. No radiographic signs of pulp pathologies such as (widening of the PDL, internal or external root resorption, apical or furcal radiolucency)

Exclusion criteria

Exclusion criteria: 1. Parents who refuse to consent 2. Non-restorable primary molars 3. Teeth with clinical or radiographic signs of pulpal involvement 4. More than two-thirds of physiologic root resorption

Design outcomes

Primary

Measure	Time frame
Treated teeth will be followed up for clinical and radiographic evaluation at 6 and 12 months: 1. Clinical criteria: a modification of the United States Public Health Service (USPHS) criteria will be used to evaluate the following parameters: retention, color matching, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and postoperative sensitivity. Restorations will be scored as “Alpha” (ideal clinical outcome), “Bravo” (clinically acceptable), or “Charlie” (clinically unacceptable). 2. Radiographic criteria: secondary caries, detectable radiolucency, furcal radiolucency, periapical radiolucency. Restorations will be scored for radiographic evaluations as “Alpha” (no evidence of secondary caries, no detectable radiolucencies, no periradicular, or furcal radiolucency), “Charlie” (evidence of caries along the margin of the restoration, radiolucencies adjacent to the restoration, and presence of periradicular or furcal radiolucency). Teeth will be evaluated clinically and radiographically by two calibrated blinded experienced dentists. The inter and intra- examiner reliability will be calculated using Cohen unweighted kappa statistics. Any disagreement between the evaluators will be discussed and if no consensus was reached the worst evaluation will be considered.	—

Measure

Time frame

Treated teeth will be followed up for clinical and radiographic evaluation at 6 and 12 months: 1. Clinical criteria: a modification of the United States Public Health Service (USPHS) criteria will be used to evaluate the following parameters: retention, color matching, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and postoperative sensitivity. Restorations will be scored as “Alpha” (ideal clinical outcome), “Bravo” (clinically acceptable), or “Charlie” (clinically unacceptable). 2. Radiographic criteria: secondary caries, detectable radiolucency, furcal radiolucency, periapical radiolucency. Restorations will be scored for radiographic evaluations as “Alpha” (no evidence of secondary caries, no detectable radiolucencies, no periradicular, or furcal radiolucency), “Charlie” (evidence of caries along the margin of the restoration, radiolucencies adjacent to the restoration, and presence of periradicular or furcal radiolucency). Teeth will be evaluated clinically and radiographically by two calibrated blinded experienced dentists. The inter and intra- examiner reliability will be calculated using Cohen unweighted kappa statistics. Any disagreement between the evaluators will be discussed and if no consensus was reached the worst evaluation will be considered.

—

Secondary

Measure	Time frame
The McNemar test will be used to observe temporal changes after 6, and 12 months for each group. Logistic regression might be used if needed to calculate the odds ratio	—

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026