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Clinical EffectSMART HALLNCT07792551

Clinical and Radiographic Comparison of SMART Hall and Conventional Hall Techniques in Children With Carious Primary Molars

A study testing SDF with stainless steel crown and Conventional Hall Technique in people with Clinical Effect, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Brief Summary Dental caries is one of the most common chronic diseases affecting children, particularly in primary molars, and may lead to pain, impaired function, reduced quality of life, and an increased risk of caries in permanent teeth. Read more about this study

Who is it for?
Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Clinical Effect
What is being tested?
SDF with stainless steel crown and Conventional Hall Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Oct 2026to 1 Oct 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 4 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patient-related inclusion criteria:
  • Children aged 4 to 8 years old.
  • One surface carious lesion.
  • No signs and symptoms. (e.g., no tooth pain)
  • Presence of one or more primary molar(s) with deep carious dentine.
  • Tooth-related eligibility criteria:
Show all 15Show fewer
  • Presence of active cavitated carious lesions that can be removed by an excavator are accessible with hand instruments.
  • Vital pulp with symptom-free or reversible pulpitis.
  • No spontaneous/prolonged pain or percussion pain.
  • No abnormal mobility or signs of infection (swelling, fistula, abscess).
  • Sufficient tooth structure for stainless steel crown retention.
  • Deep caries lesions radiographically extend through at least the inner half of the dentine.
  • Presence of a clear band of normal-appearing dentine between the carious lesion and the pulp in a bitewing radiograph.
  • More than 2/3 of the roots remaining.
  • No internal/external resorption or periapical/furcation pathology.

Who cannot join

  • 1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders).
  • 2. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants.
  • 3. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.
  • 4. Patients allergic/sensitive to nickel since PMCs contain nickel. 5. Cases with significant space loss or reduced mesio-distal width due to interproximal caries (making crown fitting difficult).
  • 6. Unaffected dentine between lesion and pulp cannot be confirmed clinically/radiographically.
  • 7. Presence of extensive dental caries or additional oral pathology requiring urgent or specified dental care beyond scope of study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rana Amr Abd El-Tawab Shafik A Shafik contact

+02 01124702071 ext. +0201001522599

ramr04320@gmail.com

Egypt1 site
  • Faculty of Dentistry, Cairo University, Cairo, Egypt.

    Cairo, Cairo Governorate, 11511

Other trials in Egypt

About this study

Official title: Clinical and Radiographic Evaluation of SMART Hall Versus Conventional Hall Technique In Children With Carious Primary Molars: Randomized Clinical Trial.

Brief Summary

Dental caries is one of the most common chronic diseases affecting children, particularly in primary molars, and may lead to pain, impaired function, reduced quality of life, and an increased risk of caries in permanent teeth. Managing caries in young children can be challenging because of behavioral and developmental factors, highlighting the need for minimally invasive, child-friendly treatment approaches.

Read more

The Hall Technique is an effective minimally invasive approach that uses stainless steel crowns to seal carious primary molars without caries removal, tooth preparation, or local anesthesia. It has demonstrated high clinical success and good patient acceptance. However, concerns remain regarding the activity of residual bacteria within deeper carious lesions.

The Silver-Modified Atraumatic Restorative Technique (SMART) incorporates silver diamine fluoride (SDF), which has antibacterial and remineralizing properties, before restoration and sealing. This may provide additional caries-arresting and antibacterial benefits compared with the conventional Hall Technique.

Although both techniques have shown promising clinical outcomes, there is limited evidence directly comparing the SMART Hall technique with the conventional Hall Technique, particularly regarding long-term clinical and radiographic outcomes. Therefore, the proposed study aims to evaluate whether adding SDF to the Hall Technique improves treatment success in carious primary molars. The findings may help identify an effective, minimally invasive, and child-friendly approach for managing dental caries in pediatric patients.

Read the detailed description

Dental caries continues to have a major effect on children's oral health and it is one of the most common chronic disorders impacting children globally. According to recent epidemiological research, carious lesions in primary molars are quite common in young populations, incidence rates among preschoolers and early school-aged children are estimated to be between 40 and 90%.

Consequences of this high incidence include pain, illness, impaired chewing function, a decreased quality of life, and an increased risk of caries in permanent teeth. Managing carious primary molars is further complicated by the behavioral and developmental challenges that pediatric patients often experience. This requires the use of kid-friendly, efficient, and minimally intrusive treatment techniques with less chair time and higher caries arrest.

The most popular restorative option for fixing and preserving the remaining structure of severely decayed or damaged teeth is stainless steel crowns. In 1947, they were first introduced to pediatric dentistry, first described by Engel, and then made popular by Humphrey in 1950.

For severely decayed primary teeth, stainless steel crowns (SSCs) are now a necessary restorative option. These crowns have prefabricated anatomy and come in a variety of sizes; to properly fit each tooth, they must be trimmed or contoured. This initial adjustment usually does not result in pain or discomfort, though it may cause variations in occlusal contact points.

Rationale of the Study:

Management of dental caries in primary molars remains a persistent challenge in pediatric dentistry, particularly when treating young or anxious children where conventional restorative procedures may not be well tolerated. In recent years, there has been a shift toward minimally invasive approaches that aim to control disease progression while reducing patient discomfort and the need for extensive operative procedures.

The Hall Technique is known as the gold standard method for managing carious primary molars without caries removal, local anesthesia, or tooth preparation. By sealing the carious lesion under stainless steel crown, the technique deprives cariogenic bacteria from their substrate, so this arrests the lesion progression. Despite its high success rates, concerns remain regarding the complete inactivation of residual bacteria, especially in deeper lesions.

On the other hand, SMART technique incorporates the use of silver diamine fluoride (SDF), with its antibacterial and remineralization characteristics. SDF has been shown to arrest caries effectively by inhibiting bacterial growth and promoting the formation of more resistant tooth structure. Combination of SDF with Conventional Hall Technique approach may provide an additional therapeutic benefit by enhancing bacterial control before sealing the lesion and the tooth.

Although both approaches are individually supported by evidence, there is a lack of well-designed randomized clinical trials directly comparing the combined SMART Hall technique with the conventional Hall technique in primary molars. Specifically, limited data are available regarding their comparative clinical and radiographic outcomes over time.

Therefore, this study will be made to fulfill this gap in the literature by evaluating whether the addition of SDF to the Hall technique offers a measurable advantage in terms of treatment success. The findings of this study may contribute to improving clinical decision-making and optimizing minimally invasive treatment strategies in pediatric dentistry.

Review of literature:

Dental caries is one of the most common chronic diseases affecting children around the world, especially in primary molars. Modern pediatric dentistry has moved towards less invasive and more natural methods focused on saving tooth structure and keeping pulp healthy. Among these, the Hall Technique and the Silver-Modified Atraumatic Restorative Technique have become more popular as alternatives to traditional restorative methods.

The Hall Technique is a less invasive method that seals cavities under preformed stainless-steel crowns without removing decay, using local anesthesia, or preparing the tooth. This approach isolates harmful bacteria from their food source, stopping the progression of the decay. Clinical studies have shown consistently high success rates, better cooperation from children, and positive acceptance from both patients and parents. Additionally, crowns used in the Hall Technique have provided better long-term results compared to traditional restorations, in terms of less pain, fewer infections, and a reduced need for additional treatments.

Recent research has supported the effectiveness of the Hall Technique for treating dentinal caries in primary molars. A randomized clinical study with an 18-month follow-up found that teeth treated with the Hall Technique remained symptom-free, functional, and successful on X-rays, with no major failures noted. Furthermore, a 24-month study comparing variations of the Hall Technique showed high survival rates and clinical success, reinforcing its reliability in pediatric dental settings. These results underline the technique's durability and effectiveness, especially for multi-surface lesions.

However, the Hall Technique has limitations, such as concerns about aesthetics due to the metallic crowns and its inapplicability in cases where the pulp is involved or there's significant structural loss. To address some of these issues, alternative minimally invasive methods like SMART have been developed.

The SMART technique combines the antibacterial properties of silver diamine fluoride (SDF) with a restorative approach. SDF is applied to arrest bacterial activity and arrest the progression of dental caries, followed by restoration of the tooth with glass ionomer cement under the stainless-steel crown. This method not only stops further decay but also restores tooth function and promotes remineralization.

Recent controlled trials have compared the effectiveness of SMART with traditional restorative techniques. A 24-month clinical trial found no significant difference in restoration success rates between SMART and conventional approaches; however, SMART showed much higher patient satisfaction and better management of behavior. Similar studies from 2023 to 2025 indicate that SMART can effectively manage deep carious lesions, providing benefits like shorter treatment times, minimal invasiveness, and improved child cooperation.

Emerging evidence also suggests that SMART could improve clinical outcomes when combined with biological methods. A 2025 randomized clinical trial comparing one-visit and two-visit SMART procedures showed promising success rates, indicating flexibility in clinical use while still being effective. Additionally, research looking into post-treatment pain and behavior found that SDF-modified Hall techniques led to less discomfort and better cooperation among young patients.

Although both the Hall Technique and SMART are minimally invasive, there is limited direct evidence comparing the two. Ongoing randomized clinical trials are set to compare their clinical and radiographic results, treatment times, and patient experiences in children aged 3 to 9 years. These studies are crucial to find the best and most acceptable treatment for managing carious primary molars.

In summary, current literature supports both the Hall Technique and SMART as effective minimally invasive methods for managing carious primary molars. The Hall Technique shows high clinical success and durability, while SMART provides additional antimicrobial benefits and better acceptance from patients. Nonetheless, more well-designed randomized clinical trials directly comparing these two techniques are necessary, especially regarding long-term outcomes. This gap in evidence highlights the need for the current study.

Conditions
Clinical Effect
Being tested
SDF with stainless steel crown, Conventional Hall Technique
Keywords
SMART HALL, Conventional Hall Technique, SDF, Children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SDF with stainless steel crownOther

    Will apply SDF before applying the stainless steel crown with glass ionomer cement without caries removal or local anesthesia.

  • Conventional Hall TechniqueOther

    Applying stainless steel crown with glass ionomer cement without SDF and no need for preparation or caries removal or local anesthesia.

Study groups in NCT07792551
Study groupRoleWhat they receive
SMART Hall Technique, SDF before Conventional Hall Technique.ExperimentalSDF is applied before the Conventional Hall technique to arrest the bacterial action.
Receives: Other: SDF with stainless steel crown
Conventional Hall TechniqueActive comparatorHall technique will be applied using glass ionomer cement under the stainless steel crown without SDF.
Receives: Other: Conventional Hall Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical evaluation

    1. Presence of pain on percussion: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO)
    2. Presence of swelling: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO)
    3. Presence of fistula: Measuring device: Clinical examination. Measuring unit: Binary (If present: Yes , if absent: NO)
    4. Presence of mobility:

    Measuring device: Clinical examination by the back of the mirror and asking the patient if there is pain on percussion.

    Measuring unit: (If present: Yes , if absent: NO)

    Measured: 12 months

Secondary outcomes (1)
  1. Radiographic Evaluation

    1. Presence of widening of periodontal membrane space. Measuring device: DIGORA ® for windows software. Measuring unit: Binary (If Present: Yes, If absent: No)
    2. Presence of periapical radiolucency. Measuring device: DIGORA ® for windows software. Measuring unit: Binary (If Present: Yes, If absent: No)
    3. Presence of furcation involvement: Measuring device: Radiographic failure score (0-3), (0) indicates no radiographic failure and (3) indicates presence of obvious radiographic failure. Measuring unit: Binary (If Present: Yes, If absent: No)
    4. Presence of pathological root resorption. Measuring device: DIGORA ® for windows software. Measuring unit: Binary (If Present: Yes, If absent: No)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Model description
Will apply SDF before Conventional Hall Technique.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07792551
Sponsor's protocol ID
SMART Hall
Acronym
SMART HALL
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Altoukhi DH, El-Housseiny AA. Hall Technique for Carious Primary Molars: A Review of the Literature. Dent J (Basel). 2020 Jan 17;8(1):11. doi: 10.3390/dj8010011.

    PubMed 31963463
  • 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.

    PubMed 18096042
  • Santamaria RM, Gomma A, Khole MR, Splieth CH, Alkilzy M. Influence of the Hall Technique on Patient Cooperation: A Retrospective Analysis. J Clin Med. 2025 Jan 7;14(2):304. doi: 10.3390/jcm14020304.

    PubMed 39860309
  • Alshahrani A, Alamro H, Alanazi F, Alowaidi L, Alhamdan F. Assessment of Knowledge, Attitude, and Teaching of the Hall Technique Among Pediatric Dentistry Faculty in Riyadh, Saudi Arabia. Dent J (Basel). 2025 May 28;13(6):239. doi: 10.3390/dj13060239.

    PubMed 40559142
  • Mittal M, Chopra R, Kumar A, Kaur IP. Combination of Silver Diamine Fluoride and Hall Technique for Caries Management in Primary Molars: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2024 Oct;17(10):1114-1120. doi: 10.5005/jp-journals-10005-2980.

    PubMed 39650295
  • Bhatia HP, Khari PM, Sood S, Sharma N, Singh A. Evaluation of Clinical Effectiveness and Patient Acceptance of Hall Technique for Managing Carious Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):548-552. doi: 10.5005/jp-journals-10005-1699.

    PubMed 32440073
  • Min SN, Duangthip D, Phyo WM, Somboonsavatdee A, Samaranayake L, Detsomboonrat P. A Clinical Trial of 38% Silver Diamine Fluoride With Light Curing in Arresting Dentine Caries in Primary Teeth. Int Dent J. 2025 Jun;75(3):2084-2092. doi: 10.1016/j.identj.2024.12.030. Epub 2025 Jan 30.

    PubMed 39884902
  • Youssef, L. Y. W., & El Shahawy, O. A. (2025). Digital occlusal analysis and bite force evaluation of Hall technique vs stainless-steel crowns as conventional restoration of carious primary molars using T-scan: A randomized clinical trial (ClinicalTrials.gov Identifier NCT07295574). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT07295574

  • TGP Team. Stainless steel crowns in pediatric dentistry: A complete guide [Internet]. Trinity Group Purchasing; 2026 Feb [cited 2026 Jun 23]. Available from: https://tgpo.io/guides/stainless-steel-crowns-pediatric-guide

  • Sharaf, D. A., Dowidar, K., El Habashy, L. M., & Hamed, H. (2021). Hall technique versus the conventional stainless-steel crowns restoring carious primary molar teeth: A randomized controlled clinical trial. Alexandria Dental Journal, 46(3), 174-180. https://adjalexu.journals.ekb.eg/article_206251_9b36dc4aa9ed7d6c9dd0bb44ca3bf387.pdf

  • Paranjape, M. N., & Shah, P. P. (2023). Smart Hall's technique: An innovative and minimally invasive novel option for managing carious primary molars-A case report. Asian Pacific Journal of Health Sciences, 10(2), 40-42.

  • Kezawie, A., Almonaqel, M.B., Katbeh, I., Kosyreva, T., Alawwad, M., Khasan, A. et al., 2021. A comparison between Hall's technique and the conventional method of managing proximal caries in primary teeth. International Journal of Dentistry and Oral Science, 8(1), pp.1329-1336. https://doi.org/10.19070/2377-8075-21000263

  • Katika, S. B. P. (2025). Comparative evaluation of SMART Hall technique vs. conventional SS crown in primary molars: A randomized clinical trial (RCT) (ClinicalTrials.gov Identifier NCT06453005). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06453005

  • Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20.

    PubMed 33851682

Questions about this trial

What is this clinical trial studying?

A study testing SDF with stainless steel crown and Conventional Hall Technique in people with Clinical Effect, run by Cairo University 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 15 inclusion and 6 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 28 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?

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 Rana Amr Abd El-Tawab Shafik A Shafik (+02 01124702071 ext. +0201001522599, ramr04320@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical evaluation (time frame: 12 months). 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 NCT07792551, which also lists 14 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 28 Aug 2026.

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