Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements

NCT04875468 | Unknown

• 1 other identifier: 28611222102086
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the clinical outcomes (marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction) of translucent zirconia crowns bonded by TheraCem (MDP, calcium and fluoride releasing) self-adhesive resin cement compared to multilink self-adhesive resin cement.

Conditions

Destructed Teeth Restored by Zirconia Crowns; Zirconia Crowns; Decayed, Missing, and Filled Teeth; Tooth Discoloration

Keywords

Marginal adaptation, patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Marginal discoloration

  Alpha (A): no discoloration (There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacement. (visual inspection) Bravo (B): discoloration without axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. (visual inspection) Charlie (C): discoloration with axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction. (visual inspection

  9 months

Secondary Outcomes (2)

• Marginal Adaptation

  9 months

• Patient satisfaction

  9 months

Study Arms (2)

Zirconia crown cemented by adhesive resin cement

ACTIVE COMPARATOR

MultiRein link adhesive resin cement (non MDP, non-calcium and fluoride releasing cement)

Other: Multilink adhesive resin cement

Zirconia crown cemented by self-adhesive resin cement

EXPERIMENTAL

TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement)

Other: TheraCem self-adhesive resin cement

Interventions

TheraCem self-adhesive resin cement OTHER

MDP, calcium and fluoride releasing cement for dental zirconia crowns

Zirconia crown cemented by self-adhesive resin cement

Multilink adhesive resin cement OTHER

(non MDP, non-calcium and fluoride releasing cement)

Zirconia crown cemented by adhesive resin cement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects are required to be:
• From 18-50 years old, be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases, have teeth with good restorations
• Psychologically and physically able to withstand conventional dental procedures
• Patients with teeth problems indicated for single crowns:
• Badly decayed teeth
• Teeth restored with large filling restorations
• Endodontically treated teeth
• Malformed teeth
• Malposed teeth (Tilted, over-erupted, rotated, etc.)
• Spacing between teeth
• Able to return for follow-up examinations and evaluation.

You may not qualify if:

• \. Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal disease 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5. Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or unrealistic expectations

Sponsors & Collaborators

• Diana Mostafa Habeb: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Giza Governorate, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries; Tooth Discoloration; Patient Satisfaction

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Diana Mostafa Habeb, Msc of fixed Prosthodontics

CONTACT

+201096643699; diana.mustafa@dentistry.cu.edu.eg

Ashraf Mokhtar, Professor

CONTACT

+201001443006

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Fixed Prosthodontics

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 6, 2021
• Study Start: May 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

EG (1)