Dental CariesNCT07530835
Occlusal Changes After Modified Hall Technique in Molars Affected by Molar-Incisor Hypomineralization
A study testing Modified Hall Technique in people with Dental Caries and Dental Occlusion, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Molar-incisor hypomineralization (MIH) frequently affects permanent first molars and increases the risk of rapid post-eruptive breakdown and restorative failure. Stainless steel crowns (SSCs) are considered a reliable treatment option for severely affected molars; however, SSC placement may temporarily alter the… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Occlusion, Pediatric Dentistry
- What is being tested?
- Modified Hall Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Dec 2027
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Absence of any skeletal anomalies
- ASA physical status I or II according to the American Society of Anesthesiologists classification
- Frankl behavior rating score of 3 or 4
- All permanent first molars erupted and in contact at maximum intercuspation
- Emergency dental needs (e.g., toothache or acute conditions) previously managed
- Presence of at least one permanent first molar with an MIH-TNI score of 2 or 4 requiring SSC restoration
Show all 12Show fewer
- No pain, clicking, or functional limitation in the temporomandibular joint region
- Children and their legal guardians who read, understand, and provide written and verbal informed consent Inclusion Criteria for Tooth
- Permanent first molars with MIH Treatment Need Index (MIH-TNI) score of 2 or 4 indicating the need for SSC restoration
- Occlusal contact with the opposing tooth maintained at maximum intercuspation despite post-eruptive enamel breakdown, with a noticeable reduction in posterior occluso-vertical dimension
- Absence of clinical and radiographic signs or symptoms associated with irreversible pulp inflammation or necrosis
- Absence of gingival or periodontal pathology in the surrounding soft tissues
Who cannot join
- Individuals with serious systemic or psychological conditions
- Participants who fail to attend follow-up appointments
- Those who exhibit excessive fear or anxiety reactions and are unable to cooperate during treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University Faculty of Dentistry
Ankara, Keçiören, 06620
Ayşe I. Cihan, Professor, 00905325095961, isilcihan@yahoo.com
About this study
Official title: Evaluation of the Occlusal Effects of Stainless Steel Crowns Placed Using the Modified Hall Technique in Permanent Molars Affected by Molar-Incisor Hypomineralization
Molar-incisor hypomineralization (MIH) frequently affects permanent first molars and increases the risk of rapid post-eruptive breakdown and restorative failure. Stainless steel crowns (SSCs) are considered a reliable treatment option for severely affected molars; however, SSC placement may temporarily alter the occlusal vertical dimension and occlusal contacts. Quantitative evidence describing the occlusal adaptation process following SSC placement in MIH-affected permanent molars is limited.
This prospective longitudinal clinical study aims to evaluate occlusal adaptation after SSC placement using the modified Hall technique in MIH-affected permanent first molars. Forty-six children will be included. Intraoral scans will be obtained at baseline, immediately after treatment, and during follow-up visits up to 3 months. Digital models will be superimposed to measure three-dimensional changes in cusp position, occluso-vertical dimension, and occlusal contact area. Temporomandibular joint function and periodontal parameters will also be assessed. The results are expected to provide quantitative evidence on occlusal adaptation following SSC treatment in MIH-affected molars.
Read the detailed description
The aim of this study is:
- to evaluate the occlusal adaptation process following SSC placement using the modified Hall technique in first permanent molars affected by MIH.
- to quantify three-dimensional occlusal changes, including cusp displacement, occluso-vertical dimension changes, and occlusal contact area alterations over time using digital model superimposition.
- to investigate the potential effects of this treatment on surrounding structures by assessing temporomandibular joint function and periodontal parameters.
MIH is a developmental enamel defect primarily affecting permanent first molars and often leading to hypersensitivity, rapid post-eruptive enamel breakdown, and significant coronal destruction. Recent literature has increasingly recommended biologically oriented and minimally invasive approaches for restoring MIH-affected molars, including the Hall technique and its modifications, which allow SSC placement without conventional tooth preparation. Although SSC placement is clinically successful, it may temporarily increase the occluso-vertical dimension and alter occlusal contacts. While clinical observations suggest that occlusal relationships gradually adapt over time through dentoalveolar compensation, no studies to date have quantitatively evaluated three-dimensional occlusal adaptation following SSC placement in MIH-affected permanent molars.
This prospective longitudinal clinical study will include 46 children with MIH-affected first permanent molars requiring SSC restoration. SSCs will be placed using the modified Hall technique.
Teeth will be equally distributed between maxillary and mandibular arches (23 maxillary and 23 mandibular molars), with only one tooth included per participant. Eligibility for SSC placement will be determined using the MIH-TNI index; teeth with scores 2 and 4 will be considered for inclusion. In cases where more than one first permanent molar meets the inclusion criteria within the same patient, the tooth showing the greatest degree of coronal breakdown will be selected for SSC placement. If multiple teeth present with similar severity level, tooth selection will be determined by computer-generated randomization. To minimize potential occlusal interference during treatment, all other necessary restorative procedures will be completed before SSC placement. Any additional teeth requiring SSC restoration will receive caries management during initial visits, while crown placement for those teeth will be postponed for three months to avoid interference with occlusal assessment.
In cases with tight proximal contacts, orthodontic separators will be placed prior to the procedure and left in situ for 3-5 days to achieve adequate interproximal space. At the SSC placement visit, lip and cheek retractors will be positioned to facilitate clear visualization of the teeth and surrounding soft tissues. Saliva will be removed using high-volume suction, and the tooth surfaces will be dried with an air syringe. Intraoral digital scans of both arches, together with the intercuspal occlusal relationship, will be obtained using a standardized scanning protocol.
Local anesthesia will be administered when clinically indicated. Unsupported hypomineralized enamel and defective restorations will be removed while maintaining a minimally invasive approach and avoiding conventional tooth preparation. Carious dentin will be removed according to selective caries removal principles: to firm dentin in shallow and moderately deep lesions and to soft dentin in deep lesions in order to prevent pulpal exposure.
An appropriately sized SSC (KidsCrown Permanent Molar SSC; Shinhung Co., Ltd., Korea) will be selected and tried in. Marginal adaptation and crown seating will be evaluated, and adjustments will be performed if necessary. The tooth will then be cleaned, dried, and isolated with cotton rolls. A glass ionomer cement (Ketac Cem Easymix; 3M ESPE, USA) will be prepared according to the manufacturer's instructions and placed inside the crown. The crown will be seated using finger pressure, and the patient will be asked to bite on a cotton roll until complete seating is achieved. Excess cement will be removed and interproximal remnants will be cleared using dental floss.
Following SSC placement, intraoral scanning will be repeated. Marginal adaptation of the crown will be verified using a bitewing radiograph obtained as part of the routine post-placement clinical assessment.
Occlusal changes following SSC placement will be monitored using digital models obtained at T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement). In addition, temporomandibular joint examination and periodontal evaluation of the tissues surrounding the crowned tooth will be performed at T0, T2, T3, and T4 follow-up visits, and the findings will be recorded.
- Conditions
- Dental Caries, Dental Occlusion, Pediatric Dentistry
- Being tested
- Modified Hall Technique
- Keywords
- Hall Technique, Occlusal adjustment, Occlusal vertical dimension, Intraoral scanning
- Medical subject headings
- Dental Caries, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Hall TechniqueProcedure or surgery
A preformed SSC will be placed on the selected MIH-affected first permanent molar using the modified Hall technique. The procedure will involve selective caries removal while maintaining a minimally invasive approach and avoiding conventional tooth preparation. Local anesthesia will be administered only when clinically indicated.
Digital Scan and Bite Registration Schedule
- T0 (Baseline): Immediately before crown placement
- T1 (Immediate): Immediately after crown placement
- T2 (Two Weeks): Two weeks after crown placement
- T3 (One Month): One month after crown placement
- T4 (Three Months): Three months after crown placement.
At each time point (T0-T4), digital scans of both the maxillary and mandibular arches will be obtained, and a buccal bite registration will be recorded.
In addition, temporomandibular joint examination and periodontal evaluation of the tissues surrounding the crowned tooth will be performed at T0, T2, T3, and T4 follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary First Permanent Molar | Experimental | A preformed SSC will be placed and cemented on the selected MIH-affected first permanent molar using the modified Hall technique. The procedure will involve selective caries removal while avoiding conventional tooth preparation, and local anesthesia will be administered only when clinically indicated.
Digital intraoral scans and bite registrations will be obtained at T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement) for occlusal analysis. Receives: Procedure: Modified Hall Technique |
| Mandibular First Permanent Molar | Active comparator | A preformed SSC will be placed and cemented on the selected MIH-affected mandibular first permanent molar using the modified Hall technique. The procedure will involve selective caries removal while maintaining a minimally invasive approach and avoiding conventional tooth preparation. Local anesthesia will be administered only when clinically indicated.
Digital intraoral scans and bite registrations will be obtained at T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement) for occlusal analysis. Receives: Procedure: Modified Hall Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cusp Tip Displacement (Linear Measurement in mm)
Positional changes of the mesiobuccal, mesiolingual/palatal, distobuccal, and distolingual/palatal cusp tips of all first permanent molars, including the crowned tooth, will be measured and recorded in millimeters using digital model superimposition across time points. In cases where one or more cusp tips of the crowned tooth are absent due to coronal breakdown, the distances between the corresponding cusp tips of the stainless-steel crown and their projected anatomical locations on the original tooth surface will be measured.
Measured: From crown placement to 3 months post-placement
Anterior Vertical Distance (Linear Measurement in mm)
The vertical distance between the cusp tips of the maxillary and mandibular primary/permanent canines located on the same side as the crowned tooth will be measured at each time point: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement). Measurements will be compared across time points to evaluate potential anterior vertical positional changes associated with SSC placement. If the canine on the treated side is not clinically visible in the oral cavity, the measurement will be performed between the opposing canines in the contralateral arch.
Measured: From crown placement to 3 months post-placement
Posterior Vertical Distance (Linear Measurement in mm)
The vertical distance between the mesiobuccal cusp tips of the maxillary and mandibular first permanent molars on both the right and left sides will be measured and recorded in millimeters. Measurements will be obtained at each time point (T0: immediately before crown placement, T1: immediately after crown placement, T2: two weeks after crown placement, T3: one month after crown placement, and T4: three months after crown placement) and compared across time points to evaluate posterior vertical positional changes.
Measured: From crown placement to 3 months post-placement
Secondary outcomes (5)
Change in Maximum Occlusal Contact Area (Surface Area Measurement in mm²)
The change in maximum occlusal contact areas (in mm²) will be analyzed based on bite registration records. Since the 3Shape software does not allow direct quantitative measurement of occlusal contact areas, the analysis will be performed using the color-coded occlusal contact maps generated by the software. Specifically, the red zones representing the areas of maximum contact will be identified from the screenshots, and their surface areas will be measured using the ImageJ software. This analysis will be two-dimensional, based on calibrated screenshots, and will provide a comparative assessment of occlusal contact area changes across different time points: T0: immediately before crown placement, T1: immediately after crown placement, T2: two weeks after crown placement, T3: one month after crown placement, and T4: three months after crown placement.
Measured: From crown placement to 3 months post-placement
Assessment of Temporomandibular Joint Function (Helkimo Dysfunction Index Score)
Temporomandibular joint (TMJ) function will be assessed at predefined follow-up time points: T0 (baseline, immediately before crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement) using a pediatric-adapted modification of the Helkimo Clinical Dysfunction Index.
The index includes five parameters: maximum mouth opening, deviation during opening, joint function impairment, TMJ pain on palpation, and masticatory muscle pain. Each parameter is scored as 0 (none), 1 (mild), or 2 (severe), and the total composite dysfunction score (range: 0-10; higher scores indicate worse dysfunction) is obtained by summing all parameters.
Scores will be categorized as 0 = no dysfunction, 1-4 = mild (Grade I), 5-9 = moderate (Grade II), and ≥10 = severe dysfunction (Grade III), and recorded and compared across time points to evaluate changes in TMJ function associated with SSC placement.
Measured: From crown placement to 3 months post-placement
Assessment of Gingival Status (Gingival Index Score)
The gingival status of the tissues surrounding the SSC-treated teeth will be evaluated at each time point: T0 (immediately before crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement). The clinical condition of the gingival tissues will be assessed using the Löe and Silness Gingival Index.
Gingival conditions will be assessed at the marginal gingiva and proximal surfaces using a periodontal probe. Scores are defined as follows: 0 = normal healthy gingiva; 1 = mild inflammation (slight color change and edema, no bleeding on probing); 2 = moderate inflammation (redness, edema, glazing, bleeding on probing); 3 = severe inflammation (marked redness and edema, ulceration, possible spontaneous bleeding).
Index scores will be recorded and compared across time points to evaluate changes in gingival health associated with SSC placement.
Measured: From crown placement to 3 months post-placement
Assessment of Plaque Accumulation (Plaque Index Score)
Plaque accumulation around the SSC-treated teeth will be evaluated at each time point: T0 (immediately before crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement).Plaque accumulation will be assessed using the Silness and Löe Plaque Index.
Assessments will be performed at the marginal gingiva and proximal surfaces using a periodontal probe. Scores are defined as follows: 0 = no plaque; 1 = plaque detectable only by probe or disclosing, not visible clinically; 2 = visible plaque limited to the gingival margin; 3 = abundant plaque accumulation along the gingival margin, including interproximal areas.
Index scores will be recorded and compared across time points to evaluate changes in plaque accumulation associated with SSC placement.
Measured: From crown placement to 3 months post-placement
Assessment of Probing Depth (Linear Measurement in mm)
The periodontal status of the tissues surrounding the SSC-treated teeth will be evaluated at each time point: T0 (immediately before crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement). Probing depth will be measured in millimeters using a periodontal probe at four sites (mesiobuccal, distobuccal, mesiolingual/palatal, and distolingual/palatal) around each SSC-treated tooth. The recorded measurements will be compared across time points to evaluate potential changes in periodontal tissue status associated with SSC placement.
Measured: From crown placement to 3 months post-placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşe I. Cihan, Professor, Study chair, Ankara Yıldırım Beyazit University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530835
- Sponsor's protocol ID
- TABED 2-26-1829
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Occlusal Effects of Stainless Steel Crowns Placed Using the Modified Hall Technique in Permanent Molars Affected by Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07530835
- Acronym / sponsor ID
- TABED 2-26-1829
- Conditions
- Dental Caries, Dental Occlusion, Pediatric Dentistry
- Keywords
- Hall Technique, Occlusal adjustment, Occlusal vertical dimension, Intraoral scanning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
Molar-incisor hypomineralization (MIH) frequently affects permanent first molars and increases the risk of rapid post-eruptive breakdown and restorative failure. Stainless steel crowns (SSCs) are considered a reliable treatment option for severely affected molars; however, SSC placement may temporarily alter the occlusal vertical dimension and occlusal contacts. Quantitative evidence describing the occlusal adaptation process following SSC placement in MIH-affected permanent molars is limited.
This prospective longitudinal clinical study aims to evaluate occlusal adaptation after SSC placement using the modified Hall technique in MIH-affected permanent first molars. Forty-six children will be included. Intraoral scans will be obtained at baseline, immediately after treatment, and during follow-up visits up to 3 months. Digital models will be superimposed to measure three-dimensional changes in cusp position, occluso-vertical dimension, and occlusal contact area. Temporomandibular joint function and periodontal parameters will also be assessed. The results are expected to provide quantitative evidence on occlusal adaptation following SSC treatment in MIH-affected molars.
Detailed description
The aim of this study is:
- to evaluate the occlusal adaptation process following SSC placement using the modified Hall technique in first permanent molars affected by MIH.
- to quantify three-dimensional occlusal changes, including cusp displacement, occluso-vertical dimension changes, and occlusal contact area alterations over time using digital model superimposition.
- to investigate the potential effects of this treatment on surrounding structures by assessing temporomandibular joint function and periodontal parameters.
MIH is a developmental enamel defect primarily affecting permanent first molars and often leading to hypersensitivity, rapid post-eruptive enamel breakdown, and significant coronal destruction. Recent literature has increasingly recommended biologically oriented and minimally invasive approaches for restoring MIH-affected molars, including the Hall technique and its modifications, which allow SSC placement without conventional tooth preparation. Although SSC placement is clinically successful, it may temporarily increase the occluso-vertical dimension and alter occlusal contacts. While clinical observations suggest that occlusal relationships gradually adapt over time through dentoalveolar compensation, no studies to date have quantitatively evaluated three-dimensional occlusal adaptation following SSC placement in MIH-affected permanent molars.
This prospective longitudinal clinical study will include 46 children with MIH-affected first permanent molars requiring SSC restoration. SSCs will be placed using the modified Hall technique.
Teeth will be equally distributed between maxillary and mandibular arches (23 maxillary and 23 mandibular molars), with only one tooth included per participant. Eligibility for SSC placement will be determined using the MIH-TNI index; teeth with scores 2 and 4 will be considered for inclusion. In cases where more than one first permanent molar meets the inclusion criteria within the same patient, the tooth showing the greatest degree of coronal breakdown will be selected for SSC placement. If multiple teeth present with similar severity level, tooth selection will be determined by computer-generated randomization. To minimize potential occlusal interference during treatment, all other necessary restorative procedures will be completed before SSC placement. Any additional teeth requiring SSC restoration will receive caries management during initial visits, while crown placement for those teeth will be postponed for three months to avoid interference with occlusal assessment.
In cases with tight proximal contacts, orthodontic separators will be placed prior to the procedure and left in situ for 3-5 days to achieve adequate interproximal space. At the SSC placement visit, lip and cheek retractors will be positioned to facilitate clear visualization of the teeth and surrounding soft tissues. Saliva will be removed using high-volume suction, and the tooth surfaces will be dried with an air syringe. Intraoral digital scans of both arches, together with the intercuspal occlusal relationship, will be obtained using a standardized scanning protocol.
Local anesthesia will be administered when clinically indicated. Unsupported hypomineralized enamel and defective restorations will be removed while maintaining a minimally invasive approach and avoiding conventional tooth preparation. Carious dentin will be removed according to selective caries removal principles: to firm dentin in shallow and moderately deep lesions and to soft dentin in deep lesions in order to prevent pulpal exposure.
An appropriately sized SSC (KidsCrown Permanent Molar SSC; Shinhung Co., Ltd., Korea) will be selected and tried in. Marginal adaptation and crown seating will be evaluated, and adjustments will be performed if necessary. The tooth will then be cleaned, dried, and isolated with cotton rolls. A glass ionomer cement (Ketac Cem Easymix; 3M ESPE, USA) will be prepared according to the manufacturer's instructions and placed inside the crown. The crown will be seated using finger pressure, and the patient will be asked to bite on a cotton roll until complete seating is achieved. Excess cement will be removed and interproximal remnants will be cleared using dental floss.
Following SSC placement, intraoral scanning will be repeated. Marginal adaptation of the crown will be verified using a bitewing radiograph obtained as part of the routine post-placement clinical assessment.
Occlusal changes following SSC placement will be monitored using digital models obtained at T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement). In addition, temporomandibular joint examination and periodontal evaluation of the tissues surrounding the crowned tooth will be performed at T0, T2, T3, and T4 follow-up visits, and the findings will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxillary First Permanent Molar | Experimental | Procedure: Modified Hall TechniqueA preformed SSC will be placed and cemented on the selected MIH-affected first permanent molar using the modified Hall technique. The procedure will involve selective caries removal while avoiding conventional tooth preparation, and local anesthesia will be administered only when clinically indicated. Digital intraoral scans and bite registrations will be obtained at T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement) for occlusal analysis. |
| Mandibular First Permanent Molar | Active comparator | Procedure: Modified Hall TechniqueA preformed SSC will be placed and cemented on the selected MIH-affected mandibular first permanent molar using the modified Hall technique. The procedure will involve selective caries removal while maintaining a minimally invasive approach and avoiding conventional tooth preparation. Local anesthesia will be administered only when clinically indicated. Digital intraoral scans and bite registrations will be obtained at T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement) for occlusal analysis. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Absence of any skeletal anomalies
- ASA physical status I or II according to the American Society of Anesthesiologists classification
- Frankl behavior rating score of 3 or 4
- All permanent first molars erupted and in contact at maximum intercuspation
- Emergency dental needs (e.g., toothache or acute conditions) previously managed
Key exclusion criteria (3 listed)
- Individuals with serious systemic or psychological conditions
- Participants who fail to attend follow-up appointments
- Those who exhibit excessive fear or anxiety reactions and are unable to cooperate during treatment
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 |
|---|---|---|
| Modified Hall TechniqueA preformed SSC will be placed on the selected MIH-affected first permanent molar using the modified Hall technique. The procedure will involve selective caries removal while maintaining a minimally invasive approach and avoiding conventional tooth preparation. Local anesthesia will be administered only when clinically indicated. Digital Scan and Bite Registration Schedule * T0 (Baseline): Immediately before crown placement * T1 (Immediate): Immediately after crown placement * T2 (Two Weeks): Two weeks after crown placement * T3 (One Month): One month after crown placement * T4 (Three Months): Three months after crown placement. At each time point (T0-T4), digital scans of both the maxillary and mandibular arches will be obtained, and a buccal bite registration will be recorded. In addition, temporomandibular joint examination and periodontal evaluation of the tissues surrounding the crowned tooth will be performed at T0, T2, T3, and T4 follow-up visits. | Procedure or surgery | Mandibular First Permanent Molar, Maxillary First Permanent Molar |
Primary outcome
Cusp Tip Displacement (Linear Measurement in mm)
Time frame: From crown placement to 3 months post-placement
Positional changes of the mesiobuccal, mesiolingual/palatal, distobuccal, and distolingual/palatal cusp tips of all first permanent molars, including the crowned tooth, will be measured and recorded in millimeters using digital model superimposition across time points. In cases where one or more cusp tips of the crowned tooth are absent due to coronal breakdown, the distances between the corresponding cusp tips of the stainless-steel crown and their projected anatomical locations on the original tooth surface will be measured.
Anterior Vertical Distance (Linear Measurement in mm)
Time frame: From crown placement to 3 months post-placement
The vertical distance between the cusp tips of the maxillary and mandibular primary/permanent canines located on the same side as the crowned tooth will be measured at each time point: T0 (immediately before crown placement), T1 (immediately after crown placement), T2 (two weeks after crown placement), T3 (one month after crown placement), and T4 (three months after crown placement). Measurements will be compared across time points to evaluate potential anterior vertical positional changes associated with SSC placement. If the canine on the treated side is not clinically visible in the oral cavity, the measurement will be performed between the opposing canines in the contralateral arch.
Posterior Vertical Distance (Linear Measurement in mm)
Time frame: From crown placement to 3 months post-placement
The vertical distance between the mesiobuccal cusp tips of the maxillary and mandibular first permanent molars on both the right and left sides will be measured and recorded in millimeters. Measurements will be obtained at each time point (T0: immediately before crown placement, T1: immediately after crown placement, T2: two weeks after crown placement, T3: one month after crown placement, and T4: three months after crown placement) and compared across time points to evaluate posterior vertical positional changes.
5 secondary outcomes
Change in Maximum Occlusal Contact Area (Surface Area Measurement in mm²)
Time frame: From crown placement to 3 months post-placement
Assessment of Temporomandibular Joint Function (Helkimo Dysfunction Index Score)
Time frame: From crown placement to 3 months post-placement
Assessment of Gingival Status (Gingival Index Score)
Time frame: From crown placement to 3 months post-placement
Assessment of Plaque Accumulation (Plaque Index Score)
Time frame: From crown placement to 3 months post-placement
Assessment of Probing Depth (Linear Measurement in mm)
Time frame: From crown placement to 3 months post-placement
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 17 Apr 2026.
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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.
Ayşe I. Cihan, Professor study chair
Ankara Yıldırım Beyazit University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Hall Technique in people with Dental Caries and Dental Occlusion, run by Ankara Yildirim Beyazıt 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 12 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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?
Contact Ayşe I. Cihan, Professor (00905325095961, isilcihan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cusp Tip Displacement (Linear Measurement in mm) (time frame: From crown placement to 3 months post-placement). The study lists 3 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 17 Apr 2026.