Primary Dental CariesNCT04367649
Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition
A study testing Hall technique, Atraumatic restorative treatment and Conventional Stainless Steel Crown Restoration in people with Primary Dental Caries, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Primary Dental Caries
- What is being tested?
- Hall technique, Atraumatic restorative treatment and Conventional Stainless Steel Crown Restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- Clinical signs and symptoms of irreversible pulpilitis.
- Tooth mobility
- Spontaneous pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 stainless steel crown and will serve as a control.
- Conditions
- Primary Dental Caries
- Being tested
- Hall technique, Atraumatic restorative treatment, Conventional Stainless Steel Crown Restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall techniqueOther
- Orthodontic separators will be used to create space for fitting the stainless crown, then removed after 3-5 days
- Occlusion will be measured assessing the patient's occlusal-vertical dimensions (OVD) using a modified version of van der Zee and van Amerongen method with a millimeter probe measuring the distance from the lowest point of the gingiva, around the lower canine on the vestibular side up to the point where the tip of the upper canine ends in order to assess the degree of overbite after mounting of the crown.
- The correct crown size will be selected. The crown should cover all the cusps and approaches the contact points, with a slight feeling of "spring back." till reaching the gingival margin. Cementation will be done using glass ionomer cement
Atraumatic restorative treatmentOther
Caries removal using excavators, then restoration using glass ionomer (GIC)
Conventional Stainless Steel Crown RestorationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hall technique | Experimental | Not described Receives: Other: Hall technique |
| Atraumatic restorative treatment | Active comparator | Not described Receives: Other: Atraumatic restorative treatment |
| Stainless Steel Crown Restoration (Conventional) | Active comparator | Not described Receives: Other: Conventional Stainless Steel Crown Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the crown (for Hall and conventional techniques)
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Measured: 1 week
Success of the crown (for Hall and conventional techniques)
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Measured: 1 month
Success of the crown (for Hall and conventional techniques)
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Measured: 6 months
Success of the crown (for Hall and conventional techniques)
The presence of a satisfactory crown will be checked. Loss of the crown, perforated crown or restoration fracture are considered failures.
Measured: 12 months
Success of the atraumatic restorative technique
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.
Measured: 1 week
Success of the atraumatic restorative technique
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.
Measured: 1 month
Success of the atraumatic restorative technique
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.
Measured: 6 months
Success of the atraumatic restorative technique
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.
Measured: 12 months
Treatment (restoration) survival
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."
Measured: 1 week
Treatment (restoration) survival
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."
Measured: 1 month
Treatment (restoration) survival
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."
Measured: 6 months
Treatment (restoration) survival
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."
Measured: 12 months
Radiographic evaluation of the treatment
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
Measured: 6 months
Radiographic evaluation of the treatment
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
Measured: 12 months
Secondary outcomes (9)
Child satisfaction
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.
Measured: immediately after completion of the dental treatment procedures
Assessment of oral cleanliness (plaque)
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.
Measured: 1 week
Assessment of oral cleanliness (plaque)
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.
Measured: 1 month
Assessment of oral cleanliness (plaque)
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.
Measured: 6 months
Assessment of oral cleanliness (plaque)
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.
Measured: 12 months
Assessment of the gingival condition
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.
Measured: 1 week
Assessment of the gingival condition
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.
Measured: 1 month
Assessment of the gingival condition
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.
Measured: 6 months
Assessment of the gingival condition
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start20 Nov 2018
- Primary completion29 Nov 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Dina Sharaf, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptKarin ML Dowidar, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptLaila M El Habashy, PhD, Study chair, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367649
- Sponsor's protocol ID
- Hall technique for management
- Status last verified
- Aug 2026
- First submitted
- 25 Apr 2020
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25216660Gruythuysen 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.
PubMed 22027459Innes 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.
PubMed 16703041Santamaria 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.
PubMed 24602167Frencken 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.
PubMed 24402057Innes 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.
PubMed 26494348Innes 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.
PubMed 18096042Innes 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.
PubMed 19927456van 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.
PubMed 20932395Frencken 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.
PubMed 8915958Farag 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.
PubMed 20372951
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04367649
- Acronym / sponsor ID
- Hall technique for management
- Conditions
- Primary Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 29 Apr 2020 (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 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.
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 stainless steel crown and will serve as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hall technique | Experimental | Other: Hall technique |
| Atraumatic restorative treatment | Active comparator | Other: Atraumatic restorative treatment |
| Stainless Steel Crown Restoration (Conventional) | Active comparator | Other: Conventional Stainless Steel Crown Restoration |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (3 listed)
- Clinical signs and symptoms of irreversible pulpilitis.
- Tooth mobility
- Spontaneous pain
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 |
|---|---|---|
| Hall technique* Orthodontic separators will be used to create space for fitting the stainless crown, then removed after 3-5 days * Occlusion will be measured assessing the patient's occlusal-vertical dimensions (OVD) using a modified version of van der Zee and van Amerongen method with a millimeter probe measuring the distance from the lowest point of the gingiva, around the lower canine on the vestibular side up to the point where the tip of the upper canine ends in order to assess the degree of overbite after mounting of the crown. * The correct crown size will be selected. The crown should cover all the cusps and approaches the contact points, with a slight feeling of "spring back." till reaching the gingival margin. Cementation will be done using glass ionomer cement | Other | Hall technique |
| Atraumatic restorative treatmentCaries removal using excavators, then restoration using glass ionomer (GIC) | Other | Atraumatic restorative treatment |
| Conventional Stainless Steel Crown RestorationComplete 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 | Other | Stainless Steel Crown Restoration (Conventional) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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."
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."
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."
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."
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
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
9 secondary outcomes
Child satisfaction
Time frame: immediately after completion of the dental treatment procedures
Assessment of oral cleanliness (plaque)
Time frame: 1 week
Assessment of oral cleanliness (plaque)
Time frame: 1 month
Assessment of oral cleanliness (plaque)
Time frame: 6 months
Assessment of oral cleanliness (plaque)
Time frame: 12 months
Assessment of the gingival condition
Time frame: 1 week
Assessment of the gingival condition
Time frame: 1 month
Assessment of the gingival condition
Time frame: 6 months
Assessment of the gingival condition
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 25216660Santamaria 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.
- Background: PubMed 22027459Gruythuysen 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.
- Background: PubMed 16703041Innes 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.
- Background: PubMed 24602167Santamaria 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.
- Background: PubMed 24402057Frencken 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.
- Background: PubMed 26494348Innes 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.
- Background: PubMed 18096042Innes 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.
- Background: PubMed 19927456Innes 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.
- Background: PubMed 20932395van 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.
- Background: PubMed 8915958Frencken 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.
- Background: PubMed 20372951Farag 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.
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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.
Dina Sharaf, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Karin ML Dowidar, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Laila M El Habashy, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hall technique, Atraumatic restorative treatment and Conventional Stainless Steel Crown Restoration in people with Primary Dental Caries, run by Nourhan M.Aly at 1 site in Egypt.
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 10 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: finished, as of the sponsor's last update on 13 Aug 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success of the crown (for Hall and conventional techniques) (time frame: 1 week). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367649, which also lists 11 linked publications.
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 13 Aug 2026.