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Long-term outcomes of tooth restoration in high-caries-risk patients

36 months' clinical performance of primary incisors restorations among high-caries-risk patients depending on the type of restorative technique used: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN64028277
Enrollment
84
Registered
2021-08-11
Start date
2017-05-01
Completion date
Unknown
Last updated
2022-03-01

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

Conditions

Primary incisors restoration Oral Health

Interventions

The study compares the results of 36 months of clinical performance of primary incisors restorations using an incremental layering technique with the nano-ceramic composite ceram.x® SphereTECTM one (D
2) examination of maxillofacial area, oral cavity, dentition, and soft tissues
3) radiographic assessment of hard teeth and periapical tissues (periapical X-ray in all cases
4) caries risk assessment. Intraoral radiography was used to detect any abnormalities of the crown and root structures as well as the surrounding bone. Periapical X-ray at maxillary c

Sponsors

Institute of Immunology and Physiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pediatric dental patients with the presence of two class-four caries cavities on the central incisors

Exclusion criteria

Exclusion criteria: 1. History of coronary artery disease 2. Pre-excitation syndromes 3. Motor impairments (cerebral palsy and epilepsy) 4. Pacemakers 5. Drug addicts 6. Patients whose parents or guardians refused to give their consent to participate

Design outcomes

Primary

MeasureTime frame
Quality of the conducted restoration by independent observers according to the modified Ryge Criteria at baseline, 6, 12, 24, and 36 months). The cavosurface marginal discoloration and color match was evaluated visually after air-drying the tooth and after removing the plaque (if necessary).

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Russian Federation

Contacts

Public ContactAlexey Sarapultsev
a.sarapultsev@gmail.com+7 9120321691

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026