A Comparative Study of Hall Technique, Modified Hall Technique and Conventional Stainless-Steel Crown Restorations in the Treatment of Primary Molars With Proximal Caries Lesions.

• ClinicalTrials.gov Identifier: NCT04822233
• Recruitment Status: Not yet recruiting
• First Posted: March 30, 2021
• Last Update Posted: March 30, 2021
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Nat Salako, The University of Texas Health Science Center, Houston

Study Description

Brief Summary:

The purpose of this study is to compare the effectiveness of the Hall technique and modified Hall technique to the conventional Stainless-Steel Crown restoration in the treatment of primary molars with dentinal caries with or without proximal ridge intact.

Condition or disease	Intervention/treatment	Phase
Dental Caries	Device: Hall Technique (HT); Device: Modified Hall Technique (MHT); Device: Conventional Technique (CT)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of Hall Technique, Modified Hall Technique and Conventional Stainless-Steel Crown Restorations in the Treatment of Primary Molars With Proximal Caries Lesions.
• Estimated Study Start Date: May 3, 2021
• Estimated Primary Completion Date: July 4, 2022
• Estimated Study Completion Date: July 4, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hall Technique (HT)	Device: Hall Technique (HT); Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swap and dispensed in a transport medium for microbial analyses.The preformed metal crown (PMC) will placed without local anesthetic and without crimping or trimming. When the contact points are tight, an orthodontic elastic separator will be placed for 2 hours prior to PMC placement. The PMCs will be cemented with glass ionomer Ketac cem.
Experimental: Modified Hall Technique (MHT)	Device: Modified Hall Technique (MHT); Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses.This group will in addition to all the procedures for the Hall will have the Caries lesions treated with 30% Silver Diamine Fluoride (SDF) before cementation of the stainless-steel crowns.
Active Comparator: Conventional Technique (CT)	Device: Conventional Technique (CT); Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses. Conventional occlusal, proximal slicing and when necessary buccal and lingual surfaces will be carried out under local anesthesia and dental dam isolation local anesthesia.The PMC will be trimmed and crimped at the gingival margin to improve the fit, and cemented with Ketac cem.

Outcome Measures

Primary Outcome Measures :

1. Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 3 months post intervention ]
2. Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 6 months post intervention ]
3. Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 9 months post intervention ]
4. Success as assessed by number of participants with no coronal or peri-radicular pathology [ Time Frame: 12 months post intervention ]
5. Amount of time taken to complete the intervention [ Time Frame: from start of intervention to end of intervention (about 45 minutes to 11/2 hours) ]

Secondary Outcome Measures :

1. Number of participants with occlusal contact of the molars as assessed by the strip test [ Time Frame: 3 months post intervention ]
   Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
2. Number of participants occlusal contact of the molars as assessed by the strip test [ Time Frame: 6 months post intervention ]
   Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
3. Number of participants occlusal contact of the molars as assessed by the strip test [ Time Frame: 9 months post intervention ]
   Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
4. Number of participants occlusal contact of the molars as assessed by the strip test [ Time Frame: 12 months post intervention ]
   Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
5. Molar height in occlusion [ Time Frame: 3 months post intervention ]
6. Molar height in occlusion [ Time Frame: 6 months post intervention ]
7. Molar height in occlusion [ Time Frame: 9 months post intervention ]
8. Molar height in occlusion [ Time Frame: 12 months post intervention ]
9. Anterior occlusal contact [ Time Frame: 3 months post intervention ]
   Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
10. Anterior occlusal contact [ Time Frame: 6 months post intervention ]
    Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
11. Anterior occlusal contact [ Time Frame: 9 months post intervention ]
    Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
12. Anterior occlusal contact [ Time Frame: 12 months post intervention ]
    Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
13. Biofilm around the stainless steel crown as assessed by the Modified Plaque Index [ Time Frame: 3 months post intervention ]
    In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
14. Biofilm around the stainless steel crown as assessed by the Modified Plaque Index [ Time Frame: 6 months post intervention ]
    In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
15. Biofilm around the stainless steel crown as assessed by the Modified Plaque Index [ Time Frame: 9 months post intervention ]
    In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
16. Biofilm around the stainless steel crown as assessed by the Modified Plaque Index [ Time Frame: 12 months post intervention ]
    In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
17. Gingival health of the treated tooth as assessed by gingival status score [ Time Frame: 3 months post intervention ]
    Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
18. Gingival health of the treated tooth as assessed by gingival status score [ Time Frame: 6 months post intervention ]
    Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
19. Gingival health of the treated tooth as assessed by gingival status score [ Time Frame: 9 months post intervention ]
    Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
20. Gingival health of the treated tooth as assessed by gingival status score [ Time Frame: 12 months post intervention ]
    Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 8 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Medically fit children
• Children who exhibit cooperative behavior at initial bitewing radiograph procedure
• Children with symptom-free or reversible pulpitis restorable first and second primary molars in both arches
• Teeth with D1 lesions will be included
• No periapical or furcation pathologies on bite wing radiographs

Exclusion Criteria:

• Medically compromised children
• Children with uncooperative behavior during bitewing radiograph process
• Primary molars with irreversible pulpitis
• Teeth with furcation or peri radicular pathologies

Contacts and Locations

Contacts

Contact: Nathanael O Salako, BDS,MSc; (713) 486-4141; Nathanael.O.Salako@uth.tmc.edu

Contact: Audrena Hankins; (713) 486-2576; Audrena.Hankins@uth.tmc.edu

Locations

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Contact: Nathanael O Salako, BDS,MSc 713-486-4141 Nathanael.O.Salako@uth.tmc.edu

Contact: Audrena Hankins (713) 486-2576 Audrena.Hankins@uth.tmc.edu

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Nathanael O Salako, BDS,MSc; The University of Texas Health Science Center, Houston

More Information

• Responsible Party: Nat Salako, Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04822233
• Other Study ID Numbers: HSC-DB-20-1247
• First Posted: March 30, 2021
• Last Update Posted: March 30, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nat Salako, The University of Texas Health Science Center, Houston:

molars

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases