Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements
Primary Purpose
Destructed Teeth Restored by Zirconia Crowns, Zirconia Crowns, Decayed, Missing, and Filled Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TheraCem self-adhesive resin cement
Multilink adhesive resin cement
Sponsored by
About this trial
This is an interventional treatment trial for Destructed Teeth Restored by Zirconia Crowns focused on measuring Marginal adaptation, patient satisfaction
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 1. 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
Sites / Locations
- Faculty of Dentistry Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Zirconia crown cemented by adhesive resin cement
Zirconia crown cemented by self-adhesive resin cement
Arm Description
MultiRein link adhesive resin cement (non MDP, non-calcium and fluoride releasing cement)
TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Marginal Adaptation
Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.
Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.
Charlie (C) Visible evidence of crevice and penetration of explorer
Patient satisfaction
Numerical (discrete) ("0" unsatisfied - "10" satisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04875468
Brief Title
Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements
Official Title
Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Diana Mostafa Habeb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Clinical outcomes of bonded monolithic translucent zirconia crowns using two different compositions of self-adhesive resin cements (Randomized Clinical Trial)
Research question:
Will TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) give better outcomes when bonding monolithic translucent zirconia crowns to tooth structure compared to Multilink self-adhesive resin cement (non MDP, non-calcium and fluoride releasing cement) in terms of marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction?
PICOS:
P: Population: Patients requiring single zirconia crowns I: Intervention: TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) C: Comparison: Multilink adhesive resin cement (non MDP, non-calcium and fluoride releasing cement)
O: Outcomes:
Outcomes Primary outcome Marginal discoloration using USPHS for 9 months Secondary outcomes 1. Marginal adaptation
2. patient satisfaction
Statement of the problem:
Bonding of zirconia restorations to tooth structures is still challenging. The success of the restoration may be affected by the type of cement used as it may affect marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction. The effect of newly introduced TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) on the clinical behavior of bonded translucent monolithic zirconia is not yet fully reported.
Aim of the study:
- The aim of the present study is to evaluate the clinical outcomes (marginal discoloration, marginal adaptation 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.
Research null hypothesis:
-There will be no difference in color stability, marginal adaptation and patient satisfaction of translucent zirconia crowns bonded either with TheraCem or Multilink self-adhesive resin cements.
Primary objective:
The Primary outcome: Marginal discoloration using USPHS Secondary outcomes: 1. Marginal adaptation 2. Patient satisfaction
Trial design:
Parallel group, two arms, with 1:1 ratio
Methods:
A) Participants, interventions, and outcomes
Study setting: This study will be carried out on patients enrolled from the Outpatient clinic in fixed prosthodontics clinic, Faculty of Dentistry, Cairo University.
Eligibility criteria:
Inclusion criteria:
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.
Exclusion criteria:
Patient less than 18 or more than 50 years
Patient with active resistant periodontal disease
Patients with poor oral hygiene and uncooperative patients
Pregnant women
Patients in the growth stage with partially erupted teeth
Psychiatric problems or unrealistic expectations
Interventions:
TheraCem (MDP containing - calcium and fluoride releasing self-adhesive resin cement).
Outcomes The outcomes will be assessed at the following time points
T0 = immediately after restoration delivery
Primary 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 Secondary 1.Marginal Adaptation Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.
Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.
Charlie (C) Visible evidence of crevice and penetration of explorer 2.Patient satisfaction Numerical (discrete) ("0" unsatisfied - "10" satisfied)
Participant timeline:
- The patient will be treated in visits designated as follows:
Visit 1: Pre-operative records, face-to-face adherence reminder session, clinical, radiographic examination, intraoral photographs and primary impression (alginate impression*) for diagnostic cast construction.
Visit 2: Teeth preparation, secondary impression using addition silicone rubber base material† and temporary restoration‡.
Visit 3: Try in Visit 4: placement and permanent cementation of the final restoration.
* Marginal discoloration, color stability, marginal adaptation and patient satisfaction will be evaluated immediately after cementation.
Recall visits:
The same evaluators evaluated the participants during the recall appointments with a mirror and a sharp explorer at 3 months, 6 months, and 9 months. Periapical radiographs were made and postoperative data were collected and used as a documentation tool with the clinical photographs. Marginal adaptation, esthetics, patient satisfaction and clinical examination were assessed using USPH After delivering the crowns, the participants were asked to rate the level of the satisfaction with their restorations by using a 1 to 10 numeric rating scale (1=poor, 5=acceptable, 10=excellent) at 3 months, 6 months and 9 months. Mean, standard deviation and 95% confidence interval for the mean were used to summarize patient satisfaction.
Data collection methods:
Primary outcome: Marginal discoloration will be assessed by using HSPHS criteria Secondary outcomes: 1. Marginal adaptation will be assessed using the modified USPHS criteria.
2. Patient satisfaction will be assessed by using normal scores numerical score from 1 to 10 (1=poor, 5=acceptable, 10=excellent)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Destructed Teeth Restored by Zirconia Crowns, Zirconia Crowns, Decayed, Missing, and Filled Teeth, Tooth Discoloration
Keywords
Marginal adaptation, patient satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zirconia crown cemented by adhesive resin cement
Arm Type
Active Comparator
Arm Description
MultiRein link adhesive resin cement (non MDP, non-calcium and fluoride releasing cement)
Arm Title
Zirconia crown cemented by self-adhesive resin cement
Arm Type
Experimental
Arm Description
TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement)
Intervention Type
Other
Intervention Name(s)
TheraCem self-adhesive resin cement
Intervention Description
MDP, calcium and fluoride releasing cement for dental zirconia crowns
Intervention Type
Other
Intervention Name(s)
Multilink adhesive resin cement
Intervention Description
(non MDP, non-calcium and fluoride releasing cement)
Primary Outcome Measure Information:
Title
Marginal discoloration
Description
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Marginal Adaptation
Description
Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.
Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.
Charlie (C) Visible evidence of crevice and penetration of explorer
Time Frame
9 months
Title
Patient satisfaction
Description
Numerical (discrete) ("0" unsatisfied - "10" satisfied)
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
1. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Mostafa Habeb, Msc of fixed Prosthodontics
Phone
+201096643699
Email
diana.mustafa@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf Mokhtar, Professor
Phone
+201001443006
Facility Information:
Facility Name
Faculty of Dentistry Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Mostafa Habeb
Phone
+20109643699
Email
diana.mustafa@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements
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