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Randomized clinical trial of the efficacy of universal and fifth generation adhesives in restored fractured anterior teeth of children aged 8-16years

Randomized clinical trial of the efficacy of universal and fifth generation adhesives in restored fractured anterior teeth of children aged 8-16years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202310536055770
Enrollment
70
Registered
2023-10-25
Start date
2023-09-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Oral Health

Interventions

Use of Universal adhesive in composite restoration of fractured anterior teeth
fifth generation adhesive in restoration of fractured anterior teeth

Sponsors

Dr Raymond Stanley Chukwunonso
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1. Patient must be between ages 8 and 16 years. 2. Patient must have or be willing to maintain a good oral hygiene. 3. Patient/parent must be willing to participate and the parent or guardian must be willing to sign the informed consent form 4. Patient with enamel-dentine fracture, ICD-11 code NA0D 2, involving the central and or lateral incisors. 5. Tooth must be vital

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Patient with an acute or chronic pulpitis or dentoalveolar abscess. 2. Patient with poor oral hygiene. 3. Patient with systemic illness. 4. Patient on orthodontic appliance therapy. 5. Patient with oral and parafunctional habits such as bruxism. 6. Patient with periodontal disease and mobile teeth. 7. Cases where there is pulpal exposure or dentine is too close to the pulp. 8.Patient with enamel defects 9.Patient with accident-prone profile. 10. Inability to return for recall appointment

Design outcomes

Primary

MeasureTime frame
anticipated outcome is that the universal adhesive may be as effective as the fifth generation in composite restoration of fractured anterior teeth

Secondary

MeasureTime frame
The possible secondary outcome is that the universal adhesive may be more effective than the fifth generation adhesive

Countries

Nigeria

Contacts

Public ContactJames Olutayo

Faculty Secretary National Postgraduate Medical College of Nigeria

facsecfmcds@npmcn.edu.ng+234080745933

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026