Dental Caries in ChildrenNCT06012409
Evaluation of the Occlusal Effects of the Hall Technique and Investigation of Children's Satisfaction
An observational study of Dental Caries in Children, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Background: The Hall Technique (HT) is a non-invasive, easily applicable minimally invasive dentistry approach for managing dental caries in children. It involves placing a preformed metal crown over a tooth with decay, to seal it in and stop the decay from progressing. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Hall Technique Prefabricated Metal Crown
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2023to 1 Jan 2024
- Phase
- Observational
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Potential participants will be selected and recruited from children attending for routine dental care at Aydin Adnan Menderes University Paediatric Dentistry Clinic. Children and their parents will be invited to participate and will be included in the study after they have the study discussed with them and they agree to participate, giving informed consent. Children should meet the inclusion criteria, and/or be none of the exclusion criteria
Children are eligible for inclusion if:
- they are 5 to 9 years old;
- they fit the clinical criteria to receive a HTPMC to manage primary molars carious lesions;
- they have antagonist primary molar
- they have not had a HTPMC fitted before;
- their parents can understand what is involved in the study and have signed and given assent to participate;
- they can cooperate with dental care including having a dental impression taken; and
- their parents are willing and able to bring them to the follow-up appointments 4, and 12 weeks after the treatment.
Children will be excluded from the study if:
- They do not have a parental agreement to participate; or
- They have self-reported occlusal parafunctional habits (e.g. bruxism, constantly open mouths).
Trial locations and contacts
1 site in 1 country.
About this study
Background: The Hall Technique (HT) is a non-invasive, easily applicable minimally invasive dentistry approach for managing dental caries in children. It involves placing a preformed metal crown over a tooth with decay, to seal it in and stop the decay from progressing. However, it alters the occlusion as no tooth substance is removed to make space for the crown.
Objective: This study, aims to evaluate the effects of Hall Technique on occlusion in children, to assess whether there are any adverse effects on the temporomandibular joint and masseter muscles, related to changes on occlusion and to evaluate the children's perceptions of the crowns.
Read more
Materials and Methods: A total of 37 children aged 5-9 years, who have not been treated with the Hall Technique previously and who have dentinal caries that did not reach the pulp (affecting the occlusal or the occluso-proximal surfaces) in their primary molars, will be invited to participate in the study. At the first visit, clinical examination will be carried out and intraoral impressions will be taken for pre-treatment evaluation. The occlusal vertical dimension of the teeth will be measured clinically with callipers. Temporomandibular joint and masseter muscles will be examined clinically. Then, the Hall Technique crown will be placed to treat the carious tooth, the impressions taken again, and measurements repeated. At one and three months following treatment with the crown, the participant will have the measurements repeated. The child and parent will complete a questionnaire after 3 months on their perception of the crown.
In the data analysis, frequency, percentage, mean and standard deviation analyses will be used for demographic data and description of the clinical data. In numerical data analysis, t-test or Mann-Whitney U test will be used according to the data distribution. Geomagic software will be used to analyse sequential study models of the teeth to measure relative changes in the tooth positions over time.
Read the detailed description
Dental caries is one of the most common chronic diseases during childhood. Due to the high incidence of dental caries in the primary dentition and inadequate treatments, early childhood caries is an important public health problem for children. The main challenge in paediatric dentistry, both for the clinician and the family, is to cooperate with the child to provide the necessary treatment successfully. Although many factors affect dental anxiety, research shows that the type of dental treatment can influence the child's behaviour. Minimally invasive dental approaches have been found to offer a more comfortable treatment process. The Hall Technique is a type of minimally invasive dental treatment. It has been used for more than 20 years to treat dental caries in children. In this technique, the carious lesion is sealed under a PMC to stop the progression of caries and prevent pain and/or infection. A crown is pressed over the tooth without local anaesthesia, tooth preparation/reduction, or carious tissue removal. This makes the technique less invasive and it can be more acceptable to children than a traditional filling involving injections and drilling.
One of the drawbacks of Hall Technique is that it increases the occlusal vertical dimension (OVD) because the PMC is placed on the tooth without any preparation. It is possible that an increase in the occlusal vertical dimension could cause hyperactivity of the masticatory muscles, an increase in occlusal forces, bruxism, and temporomandibular joint disorders. The Hall Technique has reportedly temporarily increased the vertical dimension. According to clinical research, it takes approximately a month for the vertical dimension to return its pre-treatment state.
To the best of our knowledge, none of the studies have accurately determined how the child's occlusion returns to its pre-treatment state after the placement of a Hall Technique preformed metal crown. The aim of this study is to evaluate the effects of Hall Technique on occlusion, temporomandibular joint, and masseter muscle in children and the child's perceptions of the crown.
- Conditions
- Dental Caries in Children
- Being tested
- Hall Technique Prefabricated Metal Crown
- Keywords
- Dental Caries, Children, Occlusion
- Medical subject headings
- Dental Caries, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall Technique Prefabricated Metal CrownDevice
The Hall Technique is a type of minimally invasive dental treatment. Hall Technique involves sealing the carious lesion under a Prefabricated Metal Crown to stop its progression preventing pain and/or infection.This makes the technique less invasive and it can be more acceptable to children than a traditional filling involving injections and drilling.
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Occlusal Analysis
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
Measured: Baseline
Digital Occlusal Analysis
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
Measured: Immediately After Treatment
Digital Occlusal Analysis
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
Measured: 1 Month
Digital Occlusal Analysis
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
Measured: 3 Month
Secondary outcomes (14)
Occlusal Vertical Dimension (OVD) Measurements
In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
Measured: Baseline
Occlusal Vertical Dimension (OVD) Measurements
In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored.This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
Measured: Immediately After Treatment
Occlusal Vertical Dimension (OVD) Measurements
In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
Measured: 1 month
Occlusal Vertical Dimension (OVD) Measurements
In order to determine whether OVD returns to pre-HTPMC placement levels, the occlusal vertical distance between the most prominent incisal points of the maxillary and mandibular cuspid/canine (on the same side of the jaw as that where the treatment takes place) will be scored. This will be measured in mm (from -10mm to 10mm) with a higher score indicating a worse outcome.
Measured: 3 month
Detect any negative effects on the TMJ
Clinical examination of the TMJ will be done according to AAPD Guidelines. The following questionnaire will be administered to children and parents to detect any negative effects. Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
- Yes b) No Is there pain when chewing, talking?
- Yes b) No Is there pain when opening your mouth wide or yawning?
- Yes b) No Does biting feel uncomfortable or different from normal?
- Yes b) No Have you ever had locking or dislocation of the jaw?
- Yes b) No Is there a history of jaw, head or neck injury?
- Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
- Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
Measured: Baseline
Detect any negative effects on the TMJ
Clinical examination of the TMJ will be done according to AAPD Guidelines.The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
- Yes b) No Is there pain when chewing, talking?
- Yes b) No Is there pain when opening your mouth wide or yawning?
- Yes b) No Does biting feel uncomfortable or different from normal?
- Yes b) No Have you ever had locking or dislocation of the jaw?
- Yes b) No Is there a history of jaw, head or neck injury?
- Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
- Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
Measured: Immediately after treatment
Detect any negative effects on the TMJ
Clinical examination of the TMJ will be done according to AAPD Guidelines The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
- Yes b) No Is there pain when chewing, talking?
- Yes b) No Is there pain when opening your mouth wide or yawning?
- Yes b) No Does biting feel uncomfortable or different from normal?
- Yes b) No Have you ever had locking or dislocation of the jaw?
- Yes b) No Is there a history of jaw, head or neck injury?
- Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
- Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
Measured: 1 month
Detect any negative effects on the TMJ
Clinical examination of the TMJ will be done according to AAPD Guidelines The following questionnaire will be administered to children and parents to detect any negative effects.Does he/she have difficulty opening his/her mouth? a) Yes b) No Do you hear sounds inside your jaw joint? a) Yes b) No Is there pain in the ears or cheeks? a) Yes b) No Is there pain in the jaw when chewing, talking?
- Yes b) No Is there pain when chewing, talking?
- Yes b) No Is there pain when opening your mouth wide or yawning?
- Yes b) No Does biting feel uncomfortable or different from normal?
- Yes b) No Have you ever had locking or dislocation of the jaw?
- Yes b) No Is there a history of jaw, head or neck injury?
- Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder?
- Yes b) No If so, when? How was it treated? Yes indicates a worse outcome
Measured: 3 month
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
Measured: Baseline
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects. 1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
Measured: Immediately after treatment
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
Measured: 1 month
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome
Measured: 3 month
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Masseter muscles will be examined to evaluate the clinical symptoms following placement of an HTPMC on these tissues. American Academy of Pediatric Dentistry Guidelines will be used for the examination The following questionnaire will be administered to children and parents to detect any negative effects.1. The presence of sensitivity, pain or reflected pain on palpation of the masticatory muscles and cervical muscles 0=no pain, 1=palpable pain, and 2=palpebral reflex 2. Pain on palpation of the lateral capsule of the TMJs; 0=no pain, 1=palpable pain, and 2=palpebral reflex 3. Palpation and auscultation for TMJ sounds a)Available b)None 4. Limitation of mandibular movements a)Available b)None 5. Maximum opening: 0=≥35 mm, 1=25-34 mm, 2=<25 mm 6. Deflection during movement: 0=<2mm,1=2-5mm, 2=>5 mm 7.Impaired TMJ function: a)clicking b)deadlock c)luxation 0=no impairment,1=palpable click, 2=audible click, deadlock, or luxation A higher the score, indicates a worse outcome.
Measured: 3 month
Evaluate the child's satisfaction with their HTPMC.
A questionnaire will be carried out through an interview with children to determine what their perception of HTPMC and the procedure is.
- I am happy with my fixed tooth
- I show my fixed tooth to my friends
- I feel happy if people ask to see my fixed tooth
- I can eat well with my fixed tooth
- My fixed tooth never hurts me
The scale is 0 (strongly agree) 1 (agree) 2 (no opinion) 3 (disagree) 4 (strongly disagree) A higher score indicates a worse outcome.
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start18 Feb 2023
- Primary completion1 Sep 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff University
- Responsible party
- Principal investigator, Melis AKYILDIZ, Aydin Adnan Menderes University
- Investigators
- Nicola INNES, PhD, Study chair, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012409
- Sponsor's protocol ID
- DHF-21008
- Status last verified
- Jan 2024
- First submitted
- 22 Aug 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Uribe SE, Innes N, Maldupa I. The global prevalence of early childhood caries: A systematic review with meta-analysis using the WHO diagnostic criteria. Int J Paediatr Dent. 2021 Nov;31(6):817-830. doi: 10.1111/ipd.12783. Epub 2021 Apr 30.
PubMed 33735529Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent. 2007 Nov;17(6):391-406. doi: 10.1111/j.1365-263X.2007.00872.x.
PubMed 17935593Innes 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 18096042van 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 20932395Abu Serdaneh S, AlHalabi M, Kowash M, Macefield V, Khamis AH, Salami A, Hussein I. Hall technique crowns and children's masseter muscle activity: A surface electromyography pilot study. Int J Paediatr Dent. 2020 May;30(3):303-313. doi: 10.1111/ipd.12611. Epub 2020 Jan 24.
PubMed 31894621Shih YC, Yang R, Zou J. Assessment of occlusion and temporomandibular joint after placing preformed metal crowns on all primary molars in children. Int J Paediatr Dent. 2022 Nov;32(6):915-924. doi: 10.1111/ipd.12970. Epub 2022 May 18.
PubMed 35484864Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
PubMed 31158253Hesse D, de Araujo MP, Olegario IC, Innes N, Raggio DP, Bonifacio CC. Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:169. doi: 10.1186/s13063-016-1270-z.
PubMed 27029801
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Occlusal Effects of the Hall Technique and Investigation of Children's Satisfaction
- ClinicalTrials.gov ID
- NCT06012409
- Acronym / sponsor ID
- DHF-21008
- Conditions
- Dental Caries in Children
- Keywords
- Dental Caries, Children, Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Collaborators
- Cardiff University
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 Aug 2023 (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.
Background: The Hall Technique (HT) is a non-invasive, easily applicable minimally invasive dentistry approach for managing dental caries in children. It involves placing a preformed metal crown over a tooth with decay, to seal it in and stop the decay from progressing. However, it alters the occlusion as no tooth substance is removed to make space for the crown.
Objective: This study, aims to evaluate the effects of Hall Technique on occlusion in children, to assess whether there are any adverse effects on the temporomandibular joint and masseter muscles, related to changes on occlusion and to evaluate the children's perceptions of the crowns.
Materials and Methods: A total of 37 children aged 5-9 years, who have not been treated with the Hall Technique previously and who have dentinal caries that did not reach the pulp (affecting the occlusal or the occluso-proximal surfaces) in their primary molars, will be invited to participate in the study. At the first visit, clinical examination will be carried out and intraoral impressions will be taken for pre-treatment evaluation. The occlusal vertical dimension of the teeth will be measured clinically with callipers. Temporomandibular joint and masseter muscles will be examined clinically. Then, the Hall Technique crown will be placed to treat the carious tooth, the impressions taken again, and measurements repeated. At one and three months following treatment with the crown, the participant will have the measurements repeated. The child and parent will complete a questionnaire after 3 months on their perception of the crown.
In the data analysis, frequency, percentage, mean and standard deviation analyses will be used for demographic data and description of the clinical data. In numerical data analysis, t-test or Mann-Whitney U test will be used according to the data distribution. Geomagic software will be used to analyse sequential study models of the teeth to measure relative changes in the tooth positions over time.
Detailed description
Dental caries is one of the most common chronic diseases during childhood. Due to the high incidence of dental caries in the primary dentition and inadequate treatments, early childhood caries is an important public health problem for children. The main challenge in paediatric dentistry, both for the clinician and the family, is to cooperate with the child to provide the necessary treatment successfully. Although many factors affect dental anxiety, research shows that the type of dental treatment can influence the child's behaviour. Minimally invasive dental approaches have been found to offer a more comfortable treatment process. The Hall Technique is a type of minimally invasive dental treatment. It has been used for more than 20 years to treat dental caries in children. In this technique, the carious lesion is sealed under a PMC to stop the progression of caries and prevent pain and/or infection. A crown is pressed over the tooth without local anaesthesia, tooth preparation/reduction, or carious tissue removal. This makes the technique less invasive and it can be more acceptable to children than a traditional filling involving injections and drilling.
One of the drawbacks of Hall Technique is that it increases the occlusal vertical dimension (OVD) because the PMC is placed on the tooth without any preparation. It is possible that an increase in the occlusal vertical dimension could cause hyperactivity of the masticatory muscles, an increase in occlusal forces, bruxism, and temporomandibular joint disorders. The Hall Technique has reportedly temporarily increased the vertical dimension. According to clinical research, it takes approximately a month for the vertical dimension to return its pre-treatment state.
To the best of our knowledge, none of the studies have accurately determined how the child's occlusion returns to its pre-treatment state after the placement of a Hall Technique preformed metal crown. The aim of this study is to evaluate the effects of Hall Technique on occlusion, temporomandibular joint, and masseter muscle in children and the child's perceptions of the crown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Potential participants will be selected and recruited from children attending for routine dental care at Aydin Adnan Menderes University Paediatric Dentistry Clinic. Children and their parents will be invited to participate and will be included in the study after they have the study discussed with them and they agree to participate, giving informed consent. Children should meet the inclusion criteria, and/or be none of the exclusion criteria
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 Prefabricated Metal CrownThe Hall Technique is a type of minimally invasive dental treatment. Hall Technique involves sealing the carious lesion under a Prefabricated Metal Crown to stop its progression preventing pain and/or infection.This makes the technique less invasive and it can be more acceptable to children than a traditional filling involving injections and drilling. | Device | – |
Primary outcome
Digital Occlusal Analysis
Time frame: Baseline
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
Digital Occlusal Analysis
Time frame: Immediately After Treatment
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
Digital Occlusal Analysis
Time frame: 1 Month
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
Digital Occlusal Analysis
Time frame: 3 Month
3D occlusal analysis will be performed on models taken from impressions of participants' teeth to evaluate the effects of the placement of a HTPMC on the occlusion (crowned teeth and the surrounding and opposing teeth).
14 secondary outcomes
Occlusal Vertical Dimension (OVD) Measurements
Time frame: Baseline
Occlusal Vertical Dimension (OVD) Measurements
Time frame: Immediately After Treatment
Occlusal Vertical Dimension (OVD) Measurements
Time frame: 1 month
Occlusal Vertical Dimension (OVD) Measurements
Time frame: 3 month
Detect any negative effects on the TMJ
Time frame: Baseline
Detect any negative effects on the TMJ
Time frame: Immediately after treatment
Detect any negative effects on the TMJ
Time frame: 1 month
Detect any negative effects on the TMJ
Time frame: 3 month
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time frame: Baseline
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time frame: Immediately after treatment
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time frame: 1 month
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time frame: 3 month
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time frame: 3 month
Evaluate the child's satisfaction with their HTPMC.
Time frame: 3 Month
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 11 Jan 2024.
- Background: PubMed 33735529Uribe SE, Innes N, Maldupa I. The global prevalence of early childhood caries: A systematic review with meta-analysis using the WHO diagnostic criteria. Int J Paediatr Dent. 2021 Nov;31(6):817-830. doi: 10.1111/ipd.12783. Epub 2021 Apr 30.
- Background: PubMed 17935593Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents: a review of prevalence and concomitant psychological factors. Int J Paediatr Dent. 2007 Nov;17(6):391-406. doi: 10.1111/j.1365-263X.2007.00872.x.
- 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 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 31894621Abu Serdaneh S, AlHalabi M, Kowash M, Macefield V, Khamis AH, Salami A, Hussein I. Hall technique crowns and children's masseter muscle activity: A surface electromyography pilot study. Int J Paediatr Dent. 2020 May;30(3):303-313. doi: 10.1111/ipd.12611. Epub 2020 Jan 24.
- Background: PubMed 35484864Shih YC, Yang R, Zou J. Assessment of occlusion and temporomandibular joint after placing preformed metal crowns on all primary molars in children. Int J Paediatr Dent. 2022 Nov;32(6):915-924. doi: 10.1111/ipd.12970. Epub 2022 May 18.
- Background: PubMed 31158253Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
- Background: PubMed 27029801Hesse D, de Araujo MP, Olegario IC, Innes N, Raggio DP, Bonifacio CC. Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial. Trials. 2016 Mar 31;17:169. doi: 10.1186/s13063-016-1270-z.
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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.
Nicola INNES, PhD study chair
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Jan 2024. 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 Turkey (Türkiye). 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?
Digital Occlusal Analysis (time frame: Baseline). The study lists 4 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 NCT06012409, which also lists 8 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 11 Jan 2024.