- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367649
Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition
November 2, 2020 updated by: Nourhan M.Aly
Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition (A Randomized Controlled Clinical Trial)
The aim of the present study is to evaluate both Hall technique and atraumatic restorative technique in comparison to the conventional restorative technique in the management of carious lesions in primary molars.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a three arm randomized controlled clinical trial.
Eligible children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents.
One hundred and fifty five teeth will be randomly allocated into 3 groups fifty two each.
Group I will be assigned to Hall technique Group II will be assigned to atraumatic restorative treatment using Glass ionomer cement, and Group III will be assigned to a conventional restoration and will serve as a control.
Study Type
Interventional
Enrollment (Actual)
155
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandria, Egypt, 21512
- Faculty of Dentistry, Alexandria University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children free of any systemic disease or special health care needs.
- Cooperative children ( positive/ definitely positive) according to Frankl's behavior rating scale.
- Children who are willing to participate in the study
Tooth inclusion criteria:
- Primary molar teeth with occlusal or occlusoproximal carious lesions into dentin (International Caries Detection and Assessment System) (ICDAS) codes: 3-5
- Absence of clinical signs or symptoms of irreversible pulpitis
- Absence of fistula or abscess near the selected tooth clinically and radiographically
- Absence of spontaneous pain
- Absence of pulp exposure
- Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal fossa, and gently rocking the tooth bucco-lingually.
Exclusion Criteria:
- Clinical signs and symptoms of irreversible pulpilitis.
- Tooth mobility
- Spontaneous pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hall technique
|
|
Active Comparator: Atraumatic restorative treatment
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Caries removal using excavators, then restoration using glass ionomer (GIC)
|
Sham Comparator: Conventional restorative treatment
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Complete caries removal using high-speed hand piece, and an excavator to clear carious dentin from the pulpal wall.
Then, stainless steel crown preparation, selection of the proper size with the smallest crown size that completely covers the preparation chosen.
The correct occlusogingival crown length will be established.
Cementation will be done using glass ionomer cement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of the crown (for Hall and conventional techniques)
Time Frame: 1 week
|
The presence of a satisfactory crown will be checked.
Loss of the crown, perforated crown or restoration fracture are considered failures.
|
1 week
|
Success of the crown (for Hall and conventional techniques)
Time Frame: 1 month
|
The presence of a satisfactory crown will be checked.
Loss of the crown, perforated crown or restoration fracture are considered failures.
|
1 month
|
Success of the crown (for Hall and conventional techniques)
Time Frame: 6 months
|
The presence of a satisfactory crown will be checked.
Loss of the crown, perforated crown or restoration fracture are considered failures.
|
6 months
|
Success of the crown (for Hall and conventional techniques)
Time Frame: 12 months
|
The presence of a satisfactory crown will be checked.
Loss of the crown, perforated crown or restoration fracture are considered failures.
|
12 months
|
Success of the atraumatic restorative technique
Time Frame: 1 week
|
Scoring of the restoration between 0-9.
0: Present, satisfactory.
1: Present, slight deficiency at cavity margin of less than 0.5 mm.
2: Present, slight deficiency at cavity margin of 0.5 mm or more.
3: Present, fracture in restoration.
4: Present, fracture in tooth.
5: Present, overextension of approximal margin of 0.5 mm or more.
6: Not present, most or all of restoration missing.
7: Not present, other restorative treatment performed.
8: Not present, tooth is not present.
9: Unable to diagnose.
Success scores are 0 and 1, while failure scores are 2-8.
|
1 week
|
Success of the atraumatic restorative technique
Time Frame: 1 month
|
Scoring of the restoration between 0-9.
0: Present, satisfactory.
1: Present, slight deficiency at cavity margin of less than 0.5 mm.
2: Present, slight deficiency at cavity margin of 0.5 mm or more.
3: Present, fracture in restoration.
4: Present, fracture in tooth.
5: Present, overextension of approximal margin of 0.5 mm or more.
6: Not present, most or all of restoration missing.
7: Not present, other restorative treatment performed.
8: Not present, tooth is not present.
9: Unable to diagnose.
Success scores are 0 and 1, while failure scores are 2-8.
|
1 month
|
Success of the atraumatic restorative technique
Time Frame: 6 months
|
Scoring of the restoration between 0-9.
0: Present, satisfactory.
1: Present, slight deficiency at cavity margin of less than 0.5 mm.
2: Present, slight deficiency at cavity margin of 0.5 mm or more.
3: Present, fracture in restoration.
4: Present, fracture in tooth.
5: Present, overextension of approximal margin of 0.5 mm or more.
6: Not present, most or all of restoration missing.
7: Not present, other restorative treatment performed.
8: Not present, tooth is not present.
9: Unable to diagnose.
Success scores are 0 and 1, while failure scores are 2-8.
|
6 months
|
Success of the atraumatic restorative technique
Time Frame: 12 months
|
Scoring of the restoration between 0-9.
0: Present, satisfactory.
1: Present, slight deficiency at cavity margin of less than 0.5 mm.
2: Present, slight deficiency at cavity margin of 0.5 mm or more.
3: Present, fracture in restoration.
4: Present, fracture in tooth.
5: Present, overextension of approximal margin of 0.5 mm or more.
6: Not present, most or all of restoration missing.
7: Not present, other restorative treatment performed.
8: Not present, tooth is not present.
9: Unable to diagnose.
Success scores are 0 and 1, while failure scores are 2-8.
|
12 months
|
Treatment (restoration) survival
Time Frame: 1 week
|
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
|
1 week
|
Treatment (restoration) survival
Time Frame: 1 month
|
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
|
1 month
|
Treatment (restoration) survival
Time Frame: 6 months
|
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
|
6 months
|
Treatment (restoration) survival
Time Frame: 12 months
|
ART restorations, Hall technique and conventional restorations will be scored as satisfactory will be considered "successful," while those presented minor and/or major failures will be considered as "failed."
|
12 months
|
Radiographic evaluation of the treatment
Time Frame: 6 months
|
Digital postoperative periapical radiographs will be obtained using a paralleling device to allow for exact and reproducible alignment of the dental film and the X-ray tube at the different follow up intervals.
Teeth will be considered radiographically successful if they showed no evidence of radicular radiolucency, internal or external root resorption or periodontal ligament space widening
|
6 months
|
Radiographic evaluation of the treatment
Time Frame: 12 months
|
Digital postoperative periapical radiographs will be obtained using a paralleling device to allow for exact and reproducible alignment of the dental film and the X-ray tube at the different follow up intervals.
Teeth will be considered radiographically successful if they showed no evidence of radicular radiolucency, internal or external root resorption or periodontal ligament space widening
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child satisfaction
Time Frame: immediately after completion of the dental treatment procedures
|
The patient's perception of the treatment was assessed by using a faces scale modified to represent satisfaction, indifference, or dissatisfaction .
A few minutes will be spent before each procedure to establish rapport with the child and to obtain some notion of the child's understanding of the meaning of those schematic facial expressions.
After treatment, the child will be instructed to choose the face that best represented how he/she felt during the procedure.
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immediately after completion of the dental treatment procedures
|
Assessment of oral cleanliness (plaque)
Time Frame: 1 week
|
using plaque index of Sillness and Loe.
0: No plaque.
1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen by the naked eye.
3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
|
1 week
|
Assessment of oral cleanliness (plaque)
Time Frame: 1 month
|
using plaque index of Sillness and Loe.
0: No plaque.
1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen by the naked eye.
3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
|
1 month
|
Assessment of oral cleanliness (plaque)
Time Frame: 6 months
|
using plaque index of Sillness and Loe.
0: No plaque.
1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen by the naked eye.
3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
|
6 months
|
Assessment of oral cleanliness (plaque)
Time Frame: 12 months
|
using plaque index of Sillness and Loe.
0: No plaque.
1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen by the naked eye.
3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
|
12 months
|
Assessment of the gingival condition
Time Frame: 1 week
|
using gingival index of Loe and Sillness.
0: Normal gingival.
1: Mild inflammation; slight change in color and slight edema, no bleeding on probing.
2: Moderate inflammation; redness, edema, glazing and bleeding on probing.
3: Severe inflammation; marked redness, edema, ulcerations and tendency towards spontaneous bleeding.
|
1 week
|
Assessment of the gingival condition
Time Frame: 1 month
|
using gingival index of Loe and Sillness.
0: Normal gingival.
1: Mild inflammation; slight change in color and slight edema, no bleeding on probing.
2: Moderate inflammation; redness, edema, glazing and bleeding on probing.
3: Severe inflammation; marked redness, edema, ulcerations and tendency towards spontaneous bleeding.
|
1 month
|
Assessment of the gingival condition
Time Frame: 6 months
|
using gingival index of Loe and Sillness.
0: Normal gingival.
1: Mild inflammation; slight change in color and slight edema, no bleeding on probing.
2: Moderate inflammation; redness, edema, glazing and bleeding on probing.
3: Severe inflammation; marked redness, edema, ulcerations and tendency towards spontaneous bleeding.
|
6 months
|
Assessment of the gingival condition
Time Frame: 12 months
|
using gingival index of Loe and Sillness.
0: Normal gingival.
1: Mild inflammation; slight change in color and slight edema, no bleeding on probing.
2: Moderate inflammation; redness, edema, glazing and bleeding on probing.
3: Severe inflammation; marked redness, edema, ulcerations and tendency towards spontaneous bleeding.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dina Sharaf, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
- Study Chair: Karin ML Dowidar, PhD, Faculty of Dentistry, Alexandria University, Egypt
- Study Chair: Laila M El Habashy, PhD, Faculty of Dentistry, Alexandria University, Egypt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Splieth CH. Caries management strategies for primary molars: 1-yr randomized control trial results. J Dent Res. 2014 Nov;93(11):1062-9. doi: 10.1177/0022034514550717. Epub 2014 Sep 12.
- Gruythuysen RJ, van Strijp AJ, van Palestein Helderman WH, Frankenmolen FW. [Non-restorative treatment of cavities in temporary dentition: effective and child-friendly]. Ned Tijdschr Geneeskd. 2011;155(42):A3489. Dutch.
- Innes NP, Stirrups DR, Evans DJ, Hall N, Leggate M. A novel technique using preformed metal crowns for managing carious primary molars in general practice - a retrospective analysis. Br Dent J. 2006 Apr 22;200(8):451-4; discussion 444. doi: 10.1038/sj.bdj.4813466.
- Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Alkilzy M, Splieth CH. Acceptability of different caries management methods for primary molars in a RCT. Int J Paediatr Dent. 2015 Jan;25(1):9-17. doi: 10.1111/ipd.12097. Epub 2014 Mar 7.
- Frencken JE, Holmgren CJ. Caries management through the Atraumatic Restorative Treatment (ART) approach and glass-ionomers: update 2013. Braz Oral Res. 2014;28:5-8. doi: 10.1590/S1806-83242013000600001. No abstract available.
- Innes N, Stewart M, Souster G, Evans D. The Hall Technique; retrospective case-note follow-up of 5-year RCT. Br Dent J. 2015 Oct 23;219(8):395-400. doi: 10.1038/sj.bdj.2015.816.
- Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.
- Innes N, Evans D, Hall N. The Hall Technique for managing carious primary molars. Dent Update. 2009 Oct;36(8):472-4, 477-8. doi: 10.12968/denu.2009.36.8.472.
- van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
- Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.
- Farag A, van der Sanden WJ, Abdelwahab H, Frencken JE. Survival of ART restorations assessed using selected FDI and modified ART restoration criteria. Clin Oral Investig. 2011 Jun;15(3):409-15. doi: 10.1007/s00784-010-0403-0. Epub 2010 Apr 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2018
Primary Completion (Actual)
November 29, 2019
Study Completion (Actual)
August 30, 2020
Study Registration Dates
First Submitted
April 25, 2020
First Submitted That Met QC Criteria
April 25, 2020
First Posted (Actual)
April 29, 2020
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hall technique for management
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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