Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875468
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2021-04-30
Brief Title:
Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements
Sponsor:
Diana Mostafa Habeb
Organization:
Cairo University
Study Overview
Official Title:
Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
1 From 18-50 years old be able to read and sign the informed consent document
2 Have no active periodontal or pulpal diseases have teeth with good restorations
3 Psychologically and physically able to withstand conventional dental procedures
4 Patients with teeth problems indicated for single crowns
1 Badly decayed teeth
2 Teeth restored with large filling restorations
3 Endodontically treated teeth
4 Malformed teeth
5 Malposed teeth Tilted over-erupted rotated etc
6 Spacing between teeth
5 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
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 1Marginal Adaptation Alpha A No visible evidences of crevice along the margins no catch or penetration of the explorer
Bravo B Visible evidence of crevice andor catch of explorer no penetration of the explorer
Charlie C Visible evidence of crevice and penetration of explorer 2Patient 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 1poor 5acceptable 10excellent 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 1poor 5acceptable 10excellent
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 11 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
1 From 18-50 years old be able to read and sign the informed consent document
2 Have no active periodontal or pulpal diseases have teeth with good restorations
3 Psychologically and physically able to withstand conventional dental procedures
4 Patients with teeth problems indicated for single crowns
1 Badly decayed teeth
2 Teeth restored with large filling restorations
3 Endodontically treated teeth
4 Malformed teeth
5 Malposed teeth Tilted over-erupted rotated etc
6 Spacing between teeth
5 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
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 1Marginal Adaptation Alpha A No visible evidences of crevice along the margins no catch or penetration of the explorer
Bravo B Visible evidence of crevice andor catch of explorer no penetration of the explorer
Charlie C Visible evidence of crevice and penetration of explorer 2Patient 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 1poor 5acceptable 10excellent 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 1poor 5acceptable 10excellent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None