Occlusal Changes After Modified Hall Technique in Molars Affected by Molar-Incisor Hypomineralization

NCT07530835 | Not Yet Recruiting

• 1 other identifier: TABED 2-26-1829
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dental Caries; Dental Occlusion; Pediatric Dentistry

Keywords

Hall Technique; Occlusal adjustment; Occlusal vertical dimension; Intraoral scanning

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From crown placement to 3 months post-placement

Secondary Outcomes (5)

• Change in Maximum Occlusal Contact Area (Surface Area Measurement in mm²)

  From crown placement to 3 months post-placement

• Assessment of Temporomandibular Joint Function (Helkimo Dysfunction Index Score)

  From crown placement to 3 months post-placement

• Assessment of Gingival Status (Gingival Index Score)

  From crown placement to 3 months post-placement

• Assessment of Plaque Accumulation (Plaque Index Score)

  From crown placement to 3 months post-placement

• Assessment of Probing Depth (Linear Measurement in mm)

  From crown placement to 3 months post-placement

Study Arms (2)

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.

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.

Procedure: Modified Hall Technique

Interventions

Modified Hall Technique PROCEDURE

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.

Mandibular First Permanent Molar; Maxillary First Permanent Molar

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• No pain, clicking, or functional limitation in the temporomandibular joint region
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Keçiören, 06620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries; Bites and Stings

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Ayşe I. Cihan, Professor

  Ankara Yıldırım Beyazit University Faculty of Dentistry

  STUDY CHAIR

Central Study Contacts

Ayşe I. Cihan, Professor

CONTACT

00905325095961; isilcihan@yahoo.com

Eylül Ü. Aykan

CONTACT

00905342820608; eylul.11235@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The biostatistician performing the data analysis will be blinded to group allocation. The clinician performing treatment and model analysis will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

TU (1)