Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL)

Non-carious Cervical Lesion Clinical Trial

— NCCL  

Official title:

Long-term Clinical Evaluation of Composite Restoration Using Two-steps Universal Adhesive in Non-carious Cervical Lesion: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05573243
• Other study ID #: 2022/DT086
• Status: Recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: June 2026

Study information

• Verified date: March 2023
• Source: Mahidol University
• Contact: Pipop Saikaew, PhD
• Phone: +662-200-7825
• Email: pipop045[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching strategies.

Participants will have restorations using a new 2-steps universal adhesives in different etching strategies.

• etch-and-rinse

• selective enamel etching

• self-etch

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 2026
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Available for follow-up visits

• Have at least 28 teeth/ 20 teeth under occlusion

• Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration.

Exclusion Criteria:

• Rampant / uncontrolled caries

• Advanced untreated periodontal disease

• >2 cigarette packs/day

• Systemic or local disorders that could not undergo dental procedures

• Xerostomia

• Severe bruxism, clenching, TMD

• Pregnancy at the time of screening

• Known history of sensitivity to resin or related materials

• Fixed orthodontic appliance or planning to have orthodontic treatment within 3 years

Related Conditions & MeSH terms

• Non-carious Cervical Lesion
• Uterine Cervical Diseases

Intervention

Other:
• bonding strategies
The universal adhesive can be bonded using 3 different bonding strategies. Therefore, three bonding strategies will be assigned for 3 arms: etch-and-rinse, selective enamel etching, self-etch

Locations

Country	Name	City	State
Thailand	Faculty of Dentistry, Manidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity (modified USPHS)	tooth sensitivity to hot/cold water, tactile	3 years
Primary	retention (modified USPHS)	retention rate of the restoration that retain in the mouth after treatment	3 years
Primary	secondary caries (modified USPHS)	caries recurrent rate after restoration	3 years
Secondary	marginal adaptation (modified USPHS)	the quality of the restoration margin	3 years