Dental Enamel HypomineralizationNCT06318520
Clinical Success of Stainless Steel Crowns Applied Using Different Cements
A study testing Use of Calcium silicate based resin cement and resin modified glass ionomer cement in people with Dental Enamel Hypomineralization, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Enamel Hypomineralization
- What is being tested?
- Use of Calcium silicate based resin cement and resin modified glass ionomer cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Not having any systemic disease
- No history of allergy to any medication or restorative material (local anesthesia, nickel, etc.)
- No bad habits (mouth breathing, finger sucking, etc.)
- Score 3 or score 4 on the Frankl behavior scale
- Children between the ages of 9 and 12
- Agree to come to the controls regularly during the working period
Who cannot join
- Score 1 or 2 on the Frankl behavior scale
- Molar incisor hypomineralization has not been diagnosed
- Indication for unilateral crown
- Indication for extraction
- Gingival pocket depth exceeding 3 mm
- Presence of tooth mobility, abscess, fistula
- The opposite tooth of the affected tooth is absent or not in occlusion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03030
About this study
Official title: Evaluation of the Clinical Success of Stainless Steel Crowns Applied Using Different Cements on Permanent Teeth Affected by Molar Incisor Hypomineralization
The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and resin-modified glass ionomer cement.
Read the detailed description
Molar incisor hypomineralization (MIH) is a developmental defect characterized by lack of mineralization in which one or more permanent first molars and often the incisors are also affected. In a study evaluating the prevalence of MIH in various countries, this rate was found to be 10%. It has been stated that it varies between 2.4-40. Its etiology is not known exactly, but it is thought to be due to reasons such as systemic, environmental and drug use encountered in the prenatal, perinatal and postnatal periods.
Molar incisor hypomineralization (MIH) is among the most important issues in pediatric dentistry today. Affected teeth show enamel opacities that range from white to brown depending on the duration of hypoplasia. Tooth brushing or tearing forces may cause posterior distortion, resulting in sensitivity. If dentin is exposed, resistance to tooth decay begins. Children with MIH require 10 times more treatment than normal. Although many studies can be done on etiological factors and prevalence, we are waiting for perspectives on the treatment of teeth affected by MIH. Deciding on the treatment method of teeth with MIH; the factors that produce the defect, whether the affected tooth is symptomatic or not, the age of the tooth and the expectations of the child/parent are taken into consideration. Although different restorative materials such as composite resins, glass ionomer cements or amalgam can be used in the care of these teeth, which are quite complex and difficult to treat, depending on the lesions, there is no consensus on the most effective treatment method. Since direct restorations are inadequate, especially in teeth with excessive material loss, the properties of materials that are resistant to fracture forces. Prefabricated stainless steel crowns (SSC), which have been preferred as the gold standard in long-term pediatric dentistry, are recommended for use in teeth affected by MIH. No study has been found in the accessible literature examining which bonding agent is more effective in the cementation of PCCs on teeth affected by MIH.
The aim of our study is to comparatively evaluate the 12-month clinical success of prefabricated stainless steel crowns cemented with calcium silicate-based adhesive resin cement or resin-modified glass ionomer cement on first molars diagnosed with MIH and with excessive material loss. In teeth affected by MIH, problems such as material loss, atypical restorations and sensitivity may be observed due to inorganic content and mineralization deficiency in the enamel tissue. It seems that these teeth do not last long and the treatments applied are not successful enough. It has been reported that the adhesion of restorative materials to the soft and hypomineralized enamel surface is low, therefore the risk of premature loss of restorations and secondary caries development is higher than that of healthy teeth. Therefore, stainless steel crowns are recommended as an alternative to direct restorations.
Many different materials can be used in the restoration of teeth with MIH; There are various factors affecting material selection. The severity of the defects, whether the affected tooth is symptomatic or not, the patient's dental age, the expected occlusal force for the restoration, the patient's risk of caries and oral hygiene status, and the child's/parent's expectations determine which restorative material will be used. For example; It was concluded that while conservative approaches are preferred in mild cases, the use of direct composite resin restorations, indirect restorations or metal crowns is a more appropriate treatment procedure in severe MIH cases. Restoration of teeth with MIH with SSC can prevent secondary caries, crown fractures and early tooth loss. One of the most important factors in the success of SSC is the cement material used. In recent years, self-hardening dual cure resin cements with their improved physical properties have been recommended for SSC bonding, and in vitro studies have clearly shown that they increase the success of restoration. However, no clinical study has been found in the literature showing how these cements affect the success of intraoral SSC in the long term. At the same time, although calcium silicate-based adhesive resin cements, which are a current material, have been used extensively in prosthetic studies, no study has been found in which they were used in SSC studies. One of the unique values of our study is that it is the first clinical study in which calcium silicate-based adhesive resin cements were used in SSC cementation. Another unique value is that it is the first study in which different cements were clinically compared for SSC bonding in teeth affected by MIH. We think that the results of our study will reduce the rate of recurrent treatment and therefore provide advantages to clinicians and families in terms of cost and time.
- Conditions
- Dental Enamel Hypomineralization
- Being tested
- Use of Calcium silicate based resin cement and resin modified glass ionomer cement
- Keywords
- Dental Anomaly, Enamel, Stainless Steel Crowns
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Calcium silicate based resin cement and resin modified glass ionomer cementOther
Investigators will restore MIH teeth with stainless steel crowns using calcium silicate-based resin cement and resin-modified glass ionomer cement and evaluate their 1-year success.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Calcium silicate based resin cement Receives: Other: Use of Calcium silicate based resin cement and resin modified glass ionomer cement |
| Arm 2 | Experimental | Resin modified glass ionomer cement Receives: Other: Use of Calcium silicate based resin cement and resin modified glass ionomer cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Integrity
0: The crown retains its anatomical integrity.
- The anatomical integrity of the restoration is impaired but functional.
- The restoration is fractured, displaced or completely lost.
Measured: 3. month, 6. month, 9. month, 12. month
Marginal Compliance
0: Clinically ideal. No opening is observed between crown and gingiva, no sonde enters.
- Clinically acceptable. There is an opening between the crown and gingiva that does not extend to the prepared tooth.
- Clinically unacceptable, tooth mobility and an opening extending to the prepared tooth.
Measured: 3. month, 6. month, 9. month, 12. month
Proximal Contact
0: Clinically ideal. It is possible to clean the proximal contact area with dental floss.
- Clinically acceptable. Floss passes hard or loose through the proximal contact area.
- Clinically unacceptable, proximal contact is not present.
Measured: 3. month, 6. month, 9. month, 12. month
Crown Marginal Location
- Subgingival
- Gingival level 3.Supragingival
Measured: 3. month, 6. month, 9. month, 12. month
Restoration success
- Crown appearance normal, no cracks, fractures, chips
- Inconspicuously small loss of material
- Huge loss of material
Measured: 3. month, 6. month, 9. month, 12. month
Green and Vermillion's Oral Hygiene Index
0 No plaque and discoloration
- Plaque accumulation of less than 1/3 of the tooth surface or extrinsic staining without plaque accumulation and regardless of the surface covered
- Plaque accumulation more than 1/3 and less than 2/3 of the tooth surface
- Plaque accumulation covering more than 2/3 of the tooth surface
Measured: 3. month, 6. month, 9. month, 12. month
Secondary outcomes (1)
Marginal Fit of the Crown (RADIOLOGICAL)
- There is no significant clearance between the crown and tooth surface.
- There is a significant clearance between the crown and the tooth surface.
Measured: 6. month, 12. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Aug 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Enamel HypomineralizationStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Güçyetmez Topal, Afyonkarahisar Health Sciences University
- Investigators
- Burcu GUCYETMEZ TOPAL, Asc. Prof., Study director, Afyonkarahisar Health Sciences UniversityEsma ATIS, Res. Ass., Study chair, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318520
- Sponsor's protocol ID
- AFSU-DHF-TOPAL-001
- Status last verified
- Jan 2025
- First submitted
- 13 Mar 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Success of Stainless Steel Crowns Applied Using Different Cements on Permanent Teeth Affected by Molar Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT06318520
- Acronym / sponsor ID
- AFSU-DHF-TOPAL-001
- Conditions
- Dental Enamel Hypomineralization
- Keywords
- Dental Anomaly, Enamel, Stainless Steel Crowns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 19 Mar 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.
The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and resin-modified glass ionomer cement.
Detailed description
Molar incisor hypomineralization (MIH) is a developmental defect characterized by lack of mineralization in which one or more permanent first molars and often the incisors are also affected. In a study evaluating the prevalence of MIH in various countries, this rate was found to be 10%. It has been stated that it varies between 2.4-40. Its etiology is not known exactly, but it is thought to be due to reasons such as systemic, environmental and drug use encountered in the prenatal, perinatal and postnatal periods.
Molar incisor hypomineralization (MIH) is among the most important issues in pediatric dentistry today. Affected teeth show enamel opacities that range from white to brown depending on the duration of hypoplasia. Tooth brushing or tearing forces may cause posterior distortion, resulting in sensitivity. If dentin is exposed, resistance to tooth decay begins. Children with MIH require 10 times more treatment than normal. Although many studies can be done on etiological factors and prevalence, we are waiting for perspectives on the treatment of teeth affected by MIH. Deciding on the treatment method of teeth with MIH; the factors that produce the defect, whether the affected tooth is symptomatic or not, the age of the tooth and the expectations of the child/parent are taken into consideration. Although different restorative materials such as composite resins, glass ionomer cements or amalgam can be used in the care of these teeth, which are quite complex and difficult to treat, depending on the lesions, there is no consensus on the most effective treatment method. Since direct restorations are inadequate, especially in teeth with excessive material loss, the properties of materials that are resistant to fracture forces. Prefabricated stainless steel crowns (SSC), which have been preferred as the gold standard in long-term pediatric dentistry, are recommended for use in teeth affected by MIH. No study has been found in the accessible literature examining which bonding agent is more effective in the cementation of PCCs on teeth affected by MIH.
The aim of our study is to comparatively evaluate the 12-month clinical success of prefabricated stainless steel crowns cemented with calcium silicate-based adhesive resin cement or resin-modified glass ionomer cement on first molars diagnosed with MIH and with excessive material loss. In teeth affected by MIH, problems such as material loss, atypical restorations and sensitivity may be observed due to inorganic content and mineralization deficiency in the enamel tissue. It seems that these teeth do not last long and the treatments applied are not successful enough. It has been reported that the adhesion of restorative materials to the soft and hypomineralized enamel surface is low, therefore the risk of premature loss of restorations and secondary caries development is higher than that of healthy teeth. Therefore, stainless steel crowns are recommended as an alternative to direct restorations.
Many different materials can be used in the restoration of teeth with MIH; There are various factors affecting material selection. The severity of the defects, whether the affected tooth is symptomatic or not, the patient's dental age, the expected occlusal force for the restoration, the patient's risk of caries and oral hygiene status, and the child's/parent's expectations determine which restorative material will be used. For example; It was concluded that while conservative approaches are preferred in mild cases, the use of direct composite resin restorations, indirect restorations or metal crowns is a more appropriate treatment procedure in severe MIH cases. Restoration of teeth with MIH with SSC can prevent secondary caries, crown fractures and early tooth loss. One of the most important factors in the success of SSC is the cement material used. In recent years, self-hardening dual cure resin cements with their improved physical properties have been recommended for SSC bonding, and in vitro studies have clearly shown that they increase the success of restoration. However, no clinical study has been found in the literature showing how these cements affect the success of intraoral SSC in the long term. At the same time, although calcium silicate-based adhesive resin cements, which are a current material, have been used extensively in prosthetic studies, no study has been found in which they were used in SSC studies. One of the unique values of our study is that it is the first clinical study in which calcium silicate-based adhesive resin cements were used in SSC cementation. Another unique value is that it is the first study in which different cements were clinically compared for SSC bonding in teeth affected by MIH. We think that the results of our study will reduce the rate of recurrent treatment and therefore provide advantages to clinicians and families in terms of cost and time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Use of Calcium silicate based resin cement and resin modified glass ionomer cementCalcium silicate based resin cement |
| Arm 2 | Experimental | Other: Use of Calcium silicate based resin cement and resin modified glass ionomer cementResin modified glass ionomer cement |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Not having any systemic disease
- No history of allergy to any medication or restorative material (local anesthesia, nickel, etc.)
- No bad habits (mouth breathing, finger sucking, etc.)
- Score 3 or score 4 on the Frankl behavior scale
- Children between the ages of 9 and 12
Key exclusion criteria (7 listed)
- Score 1 or 2 on the Frankl behavior scale
- Molar incisor hypomineralization has not been diagnosed
- Indication for unilateral crown
- Indication for extraction
- Gingival pocket depth exceeding 3 mm
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 |
|---|---|---|
| Use of Calcium silicate based resin cement and resin modified glass ionomer cementInvestigators will restore MIH teeth with stainless steel crowns using calcium silicate-based resin cement and resin-modified glass ionomer cement and evaluate their 1-year success. | Other | Arm 1, Arm 2 |
Primary outcome
Anatomical Integrity
Time frame: 3. month, 6. month, 9. month, 12. month
0: The crown retains its anatomical integrity. 1. The anatomical integrity of the restoration is impaired but functional. 2. The restoration is fractured, displaced or completely lost.
Marginal Compliance
Time frame: 3. month, 6. month, 9. month, 12. month
0: Clinically ideal. No opening is observed between crown and gingiva, no sonde enters. 1. Clinically acceptable. There is an opening between the crown and gingiva that does not extend to the prepared tooth. 2. Clinically unacceptable, tooth mobility and an opening extending to the prepared tooth.
Proximal Contact
Time frame: 3. month, 6. month, 9. month, 12. month
0: Clinically ideal. It is possible to clean the proximal contact area with dental floss. 1. Clinically acceptable. Floss passes hard or loose through the proximal contact area. 2. Clinically unacceptable, proximal contact is not present.
Crown Marginal Location
Time frame: 3. month, 6. month, 9. month, 12. month
1. Subgingival 2. Gingival level 3.Supragingival
Restoration success
Time frame: 3. month, 6. month, 9. month, 12. month
1. Crown appearance normal, no cracks, fractures, chips 2. Inconspicuously small loss of material 3. Huge loss of material
Green and Vermillion's Oral Hygiene Index
Time frame: 3. month, 6. month, 9. month, 12. month
0 No plaque and discoloration 1. Plaque accumulation of less than 1/3 of the tooth surface or extrinsic staining without plaque accumulation and regardless of the surface covered 2. Plaque accumulation more than 1/3 and less than 2/3 of the tooth surface 3. Plaque accumulation covering more than 2/3 of the tooth surface
1 secondary outcome
Marginal Fit of the Crown (RADIOLOGICAL)
Time frame: 6. month, 12. month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Burcu GUCYETMEZ TOPAL, Asc. Prof. study director
Afyonkarahisar Health Sciences University
Esma ATIS, Res. Ass. study chair
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Calcium silicate based resin cement and resin modified glass ionomer cement in people with Dental Enamel Hypomineralization, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Anatomical Integrity (time frame: 3. month, 6. month, 9. month, 12. month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.