Crown of Tooth With Poor ContourNCT06456879
Clinical Performance and Convenience of Four Types of Crowns for Primary Molars
A study testing extra-coronal restoration type in people with Crown of Tooth With Poor Contour, run by Mansoura University at 2 sites in Egypt.
Trial summary
This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars: The prefabricated commercially available zirconia crowns (NuSmile®) (NZC). Read more about this study
- Who is it for?
- Ages 4 to 8 years, women only
- Conditions the study is for
- Crown of Tooth With Poor Contour
- What is being tested?
- extra-coronal restoration type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Feb 2022to 17 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Children between 4-8 years old.
- Definitely positive or positive behavior according to Frankl behavior rating scale.
- The lower second primary molar with one or more indications for crown restoration.
Who cannot join
- The child does not have occlusal problems or periodontal diseases
- The child does not take medications that lead to symptoms of periodontal diseases.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 002
Mansoura university
Al Mansurah, Dakahlya, 002
About this study
Official title: Clinical Performance and Convenience of Three Types of Crowns as Esthetic Alternatives to Stainless Steel Crowns for Primary Molars
This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars:
- The prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
- The locally manufactured zirconia crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCZC).
- The locally manufactured hybrid ceramic crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCHC).
Read the detailed description
Eighty lower second primary molars will be divided into 4 groups:
- Group 1(n=20): receive 3M™ ESPE™ Stainless Steel crowns for Primary Molars.
- Group 2 (n=20): receive the prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
- Group 3 (n=20): receive the locally manufactured zirconia crowns created via (CAD/CAM) system (CCZC).
- Group 4 (n=20): receive the locally manufactured hybrid ceramic crowns created via (CAD/CAM) system (CCHC).
Clinical and radiographic examination of the primary molar will be conducted to ensure compliance with the study criteria. Oral health instructions will be given to the child and parents then the application of local anesthesia.
- Stainless steel crowns: Reduction of occlusal surface by about 1.5 mm using a flame shaped diamond bur to produce a uniform occlusal reduction. Proximal reduction using a long and tapered diamond bur to allow the probe to pass through the contact area. An appropriate size will be selected according to mesiodistal width of the prepared tooth and a trial fit will be carried out before cementation. The crown should remain no more than 1 mm subgingivally.(21)
- Zirconia and hybrid ceramic crowns: The appropriate size of the posterior crown will be selected for the tooth chosen for treatment. The occlusal surface will be reduced by 1-2 mm by using a flame bur after evaluation of the occlusal relationships. The interproximal areas will be opened followed by reduction of the crown dimensions by 0.5-1.25 mm using a tapered diamond bur making the contour of the prepared tooth consistent with the natural contour. The prepared tooth walls will be finished with a 1-2 mm subgingival feather-edge preparation using a thinner pointed tapered diamond bur. The selected crown will be tested for appropriate fit before the final cementation. Finally, the prepared tooth will be cleaned from saliva, blood, and the remnants of preparation and ready for cementation.(15) The selected crown will be cleaned and then filled with resin modified glass ionomer cement. The crown will be applied with no resistance to the fully seated position on the tooth (Passive Fit) since forcing the crown to place can produce micro-fractures in the zirconia structure. Excess cement will be removed using a dental probe and dental floss. Clinical evaluation:
- Evaluation criteria concerning the clinical performance are
- The Gingival Index (GI)(22) will be measured by the William Gingival Probe with a blunt-ended instrument gently placed within the gingival gutter around each tooth to be crowned/previously crowned, and the values will be as follows: 0 = normal gingiva
- = mild inflammation: a slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, and glazing, or bleeding on probing
- =severe inflammation: marked redness and edema, a tendency toward spontaneous bleeding, ulceration.
- Plaque Index (PI)(22) will be measured by passing the gingival probe around each tooth to be crowned/previously crowned, and the values will be as follows: 0 = no plaque
1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
Crown retention (23) will be measured as follows:
0 = present.
1 = absent.
Crown integrity(24) will be measured as follows:
0 = intact.
- = crack present.
- = fracture present.
- = crown lost.
Marginal adaptation will be measured clinically and radiographically:
- All crowns will be evaluated clinically at baseline, 3rd, 6th, 9th and 12th months and scored as follows:(25) 0 = Margin not discernible, probe does not catch.
- = Probe catches on margin but no gap on probing.
- = Probe catches on margin and a gap on probing.
- = Crown fractured or missing. 2) All crowns will be evaluated radiographically at baseline, 6th, and 12th months to check the marginal adaptation.
Color stability(26) will be measured as follows:
0 = Unchanged.
1 = Minor deviation from original. Wear of the antagonistic natural enamel. To evaluate the wear of the antagonistic natural enamel of primary molar, a rubber base impressions will be made immediately (baseline) and at 1 year after cementation. The resulting casts will be scanned (using a 3D scanner), and 3D softare will be used to calculate the maximum amount of linear wear. (27)
- Evaluation criteria regarding the crown convenience: Time elapsed since the start of tooth preparation till the crown cementation. Anxiety using the Facial Image Scale (FIS).(28) The Facial image scale comprises a row of five faces ranging from very happy to very unhappy. The children were asked to point at which face they felt most like at that moment. The scale is scored by giving a value of one to the most positive affect face and five to the most negative affect face. Facial Image Scale has a fixed number of faces (not a continuous line) for the children to choose from, thus making it easier to score in a clinical situation, and easier for very young children to understand.
- Conditions
- Crown of Tooth With Poor Contour
- Being tested
- extra-coronal restoration type
- Keywords
- crowns, molars, wear, zirconia, hybrid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra-coronal restoration typeOther
primary molar crown type
| Study group | Role | What they receive |
|---|---|---|
| Stainless Steel Crown | Active comparator | crown Receives: Other: extra-coronal restoration type |
| • NuSmile zirconia crown | Active comparator | crown Receives: Other: extra-coronal restoration type |
| • CAD CAM zirconia crown | Active comparator | crown Receives: Other: extra-coronal restoration type |
| • CAD CAM hybrid crown | Active comparator | crown Receives: Other: extra-coronal restoration type |
What is being measured
The primary outcome is the main question the study is designed to answer.
the gingival index
0 = normal gingiva
- = mild inflammation
- = moderate inflammation
- = severe inflammation
Measured: 12 months
Crown retention
0 = present.
1 = absent.
Measured: 12 months
Crown integrity
0 = intact.
- = crack present.
- = fracture present.
- = crown lost.
Measured: 12 months
Color stability
0 = Unchanged.
- = Minor deviation from original.
- = Unacceptable discoloration.
Measured: 12 months
Plaque Index
0 = no plaque
1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
Measured: 12 months
Secondary outcomes (1)
wear of opposing natural teeth.
To evaluate the wear of the antagonistic natural enamel of primary molar, the upper arch was scanned using an intraoral scanner immediately, (6 months and 1 year after cementation. Both 3d images were placed in the same position and compared using the CAD software to calculate the amount of linear wear on millimeters.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start5 Feb 2022
- Primary completion17 Jan 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crown of Tooth With Poor ContourStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana M Amer, MASTER, Principal investigator, Mansoura UniversityAbeer M Abdellatif, Phd, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456879
- Sponsor's protocol ID
- M01010222
- Status last verified
- Mar 2024
- First submitted
- 19 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amer DM, Abdellatif AM. In vivo evaluation of the enamel wear of primary molar against four types of crowns using the intra-oral scanner. BMC Oral Health. 2024 Nov 27;24(1):1438. doi: 10.1186/s12903-024-05206-5.
PubMed 39604941
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Convenience of Three Types of Crowns as Esthetic Alternatives to Stainless Steel Crowns for Primary Molars
- ClinicalTrials.gov ID
- NCT06456879
- Acronym / sponsor ID
- M01010222
- Conditions
- Crown of Tooth With Poor Contour
- Keywords
- crowns, molars, wear, zirconia, hybrid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to assess the clinical performance and convenience of three types of crowns as esthetic alternatives to stainless steel crown for primary molars:
- The prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
- The locally manufactured zirconia crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCZC).
- The locally manufactured hybrid ceramic crowns created via Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) system (CCHC).
Detailed description
Eighty lower second primary molars will be divided into 4 groups:
- Group 1(n=20): receive 3M™ ESPE™ Stainless Steel crowns for Primary Molars.
- Group 2 (n=20): receive the prefabricated commercially available zirconia crowns (NuSmile®) (NZC).
- Group 3 (n=20): receive the locally manufactured zirconia crowns created via (CAD/CAM) system (CCZC).
- Group 4 (n=20): receive the locally manufactured hybrid ceramic crowns created via (CAD/CAM) system (CCHC).
Clinical and radiographic examination of the primary molar will be conducted to ensure compliance with the study criteria. Oral health instructions will be given to the child and parents then the application of local anesthesia.
- Stainless steel crowns: Reduction of occlusal surface by about 1.5 mm using a flame shaped diamond bur to produce a uniform occlusal reduction. Proximal reduction using a long and tapered diamond bur to allow the probe to pass through the contact area. An appropriate size will be selected according to mesiodistal width of the prepared tooth and a trial fit will be carried out before cementation. The crown should remain no more than 1 mm subgingivally.(21)
- Zirconia and hybrid ceramic crowns: The appropriate size of the posterior crown will be selected for the tooth chosen for treatment. The occlusal surface will be reduced by 1-2 mm by using a flame bur after evaluation of the occlusal relationships. The interproximal areas will be opened followed by reduction of the crown dimensions by 0.5-1.25 mm using a tapered diamond bur making the contour of the prepared tooth consistent with the natural contour. The prepared tooth walls will be finished with a 1-2 mm subgingival feather-edge preparation using a thinner pointed tapered diamond bur. The selected crown will be tested for appropriate fit before the final cementation. Finally, the prepared tooth will be cleaned from saliva, blood, and the remnants of preparation and ready for cementation.(15) The selected crown will be cleaned and then filled with resin modified glass ionomer cement. The crown will be applied with no resistance to the fully seated position on the tooth (Passive Fit) since forcing the crown to place can produce micro-fractures in the zirconia structure. Excess cement will be removed using a dental probe and dental floss. Clinical evaluation:
- Evaluation criteria concerning the clinical performance are
- The Gingival Index (GI)(22) will be measured by the William Gingival Probe with a blunt-ended instrument gently placed within the gingival gutter around each tooth to be crowned/previously crowned, and the values will be as follows: 0 = normal gingiva
- = mild inflammation: a slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, and glazing, or bleeding on probing
- =severe inflammation: marked redness and edema, a tendency toward spontaneous bleeding, ulceration.
- Plaque Index (PI)(22) will be measured by passing the gingival probe around each tooth to be crowned/previously crowned, and the values will be as follows: 0 = no plaque
1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
Crown retention (23) will be measured as follows:
0 = present.
1 = absent.
Crown integrity(24) will be measured as follows:
0 = intact.
- = crack present.
- = fracture present.
- = crown lost.
Marginal adaptation will be measured clinically and radiographically:
- All crowns will be evaluated clinically at baseline, 3rd, 6th, 9th and 12th months and scored as follows:(25) 0 = Margin not discernible, probe does not catch.
- = Probe catches on margin but no gap on probing.
- = Probe catches on margin and a gap on probing.
- = Crown fractured or missing. 2) All crowns will be evaluated radiographically at baseline, 6th, and 12th months to check the marginal adaptation.
Color stability(26) will be measured as follows:
0 = Unchanged.
1 = Minor deviation from original. Wear of the antagonistic natural enamel. To evaluate the wear of the antagonistic natural enamel of primary molar, a rubber base impressions will be made immediately (baseline) and at 1 year after cementation. The resulting casts will be scanned (using a 3D scanner), and 3D softare will be used to calculate the maximum amount of linear wear. (27)
- Evaluation criteria regarding the crown convenience: Time elapsed since the start of tooth preparation till the crown cementation. Anxiety using the Facial Image Scale (FIS).(28) The Facial image scale comprises a row of five faces ranging from very happy to very unhappy. The children were asked to point at which face they felt most like at that moment. The scale is scored by giving a value of one to the most positive affect face and five to the most negative affect face. Facial Image Scale has a fixed number of faces (not a continuous line) for the children to choose from, thus making it easier to score in a clinical situation, and easier for very young children to understand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stainless Steel Crown | Active comparator | Other: extra-coronal restoration typecrown |
| • NuSmile zirconia crown | Active comparator | Other: extra-coronal restoration typecrown |
| • CAD CAM zirconia crown | Active comparator | Other: extra-coronal restoration typecrown |
| • CAD CAM hybrid crown | Active comparator | Other: extra-coronal restoration typecrown |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 4-8 years old.
- Definitely positive or positive behavior according to Frankl behavior rating scale.
- The lower second primary molar with one or more indications for crown restoration.
Key exclusion criteria (2 listed)
- The child does not have occlusal problems or periodontal diseases
- The child does not take medications that lead to symptoms of periodontal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extra-coronal restoration typeprimary molar crown type | Other | Stainless Steel Crown, • CAD CAM hybrid crown, • CAD CAM zirconia crown, • NuSmile zirconia crown |
Primary outcome
the gingival index
Time frame: 12 months
0 = normal gingiva 1. = mild inflammation 2. = moderate inflammation 3. = severe inflammation
Crown retention
Time frame: 12 months
0 = present. 1 = absent.
Crown integrity
Time frame: 12 months
0 = intact. 1. = crack present. 2. = fracture present. 3. = crown lost.
Color stability
Time frame: 12 months
0 = Unchanged. 1. = Minor deviation from original. 2. = Unacceptable discoloration.
Plaque Index
Time frame: 12 months
0 = no plaque 1= film at the gingival margin and adjacent tooth 2 = moderate accumulation of plaque 3 = abundance of plaque.
1 secondary outcome
wear of opposing natural teeth.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 39604941Amer DM, Abdellatif AM. In vivo evaluation of the enamel wear of primary molar against four types of crowns using the intra-oral scanner. BMC Oral Health. 2024 Nov 27;24(1):1438. doi: 10.1186/s12903-024-05206-5.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana M Amer, MASTER principal investigator
Mansoura University
Abeer M Abdellatif, Phd study chair
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extra-coronal restoration type in people with Crown of Tooth With Poor Contour, run by Mansoura University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the gingival index (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.