- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012409
Evaluation of the Occlusal Effects of the Hall Technique and Investigation of Children's Satisfaction
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Bahar Melis AKYILDIZ, DDS
- Phone Number: +905387970703
- Email: baharmeliss@hotmail.com
Study Locations
-
-
Aydın
-
Efeler, Aydın, Turkey, 09100
- Melis AKYILDIZ
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
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
Description
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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline
|
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).
|
Immediately After Treatment
|
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).
|
1 Month
|
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).
|
3 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occlusal Vertical Dimension (OVD) Measurements
Time Frame: Baseline
|
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.
|
Baseline
|
Occlusal Vertical Dimension (OVD) Measurements
Time Frame: Immediately After Treatment
|
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.
|
Immediately After Treatment
|
Occlusal Vertical Dimension (OVD) Measurements
Time Frame: 1 month
|
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.
|
1 month
|
Occlusal Vertical Dimension (OVD) Measurements
Time Frame: 3 month
|
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.
|
3 month
|
Detect any negative effects on the TMJ
Time Frame: Baseline
|
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? a) Yes b) No Is there pain when chewing, talking? a) Yes b) No Is there pain when opening your mouth wide or yawning? a) Yes b) No Does biting feel uncomfortable or different from normal? a) Yes b) No Have you ever had locking or dislocation of the jaw? a) Yes b) No Is there a history of jaw, head or neck injury? a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder? a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome |
Baseline
|
Detect any negative effects on the TMJ
Time Frame: Immediately after treatment
|
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? a) Yes b) No Is there pain when chewing, talking? a) Yes b) No Is there pain when opening your mouth wide or yawning? a) Yes b) No Does biting feel uncomfortable or different from normal? a) Yes b) No Have you ever had locking or dislocation of the jaw? a) Yes b) No Is there a history of jaw, head or neck injury? a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder? a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome |
Immediately after treatment
|
Detect any negative effects on the TMJ
Time Frame: 1 month
|
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? a) Yes b) No Is there pain when chewing, talking? a) Yes b) No Is there pain when opening your mouth wide or yawning? a) Yes b) No Does biting feel uncomfortable or different from normal? a) Yes b) No Have you ever had locking or dislocation of the jaw? a) Yes b) No Is there a history of jaw, head or neck injury? a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder? a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome |
1 month
|
Detect any negative effects on the TMJ
Time Frame: 3 month
|
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? a) Yes b) No Is there pain when chewing, talking? a) Yes b) No Is there pain when opening your mouth wide or yawning? a) Yes b) No Does biting feel uncomfortable or different from normal? a) Yes b) No Have you ever had locking or dislocation of the jaw? a) Yes b) No Is there a history of jaw, head or neck injury? a) Yes b) No If yes, when? How was it treated? Has he/she ever been treated for a jaw joint disorder? a) Yes b) No If so, when? How was it treated? Yes indicates a worse outcome |
3 month
|
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time Frame: Baseline
|
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
|
Baseline
|
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time Frame: Immediately after treatment
|
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
|
Immediately after treatment
|
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time Frame: 1 month
|
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
|
1 month
|
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time Frame: 3 month
|
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
|
3 month
|
Detect any negative clinical effects of placing an HTPMC on the masseter muscles.
Time Frame: 3 month
|
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.
|
3 month
|
Evaluate the child's satisfaction with their HTPMC.
Time Frame: 3 Month
|
A questionnaire will be carried out through an interview with children to determine what their perception of HTPMC and the procedure is.
The scale is 0 (strongly agree) 1 (agree) 2 (no opinion) 3 (disagree) 4 (strongly disagree) A higher score indicates a worse outcome. |
3 Month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Nicola INNES, PhD, Cardiff University
Publications and helpful links
General Publications
- 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.
- van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
- 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.
- Klingberg 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.
- Abu 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.
- Shih 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.
- Elamin 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.
- Hesse 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHF-21008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Caries in Children
-
Stephanie ShimizuUniversity of Southern CaliforniaRecruitingDental Caries in Children | Dental Caries | Dental Caries Class IIUnited States
-
Oral Health Centre of Expertise in Eastern NorwayPublic Dental Service, Hedmark; Public Dental Service, Oppland; Public Dental...Active, not recruitingDental Caries in Children | Dental Caries Pit and FissureNorway
-
Children's Hospital ColoradoRecruitingDental Caries in Children | Dental DiseasesUnited States
-
University of GlasgowMinistry of Health, Saudi ArabiaRecruiting
-
University of Sao PauloNot yet recruitingDental Caries in Children | Dental CariesBrazil
-
Suez Canal UniversityCompletedDental Caries in ChildrenEgypt
-
Advantage Silver Dental Arrest, LLCActive, not recruitingDental Caries in ChildrenUnited States Minor Outlying Islands
-
Al-Azhar UniversityActive, not recruitingDental Caries in ChildrenEgypt
-
Ahram Canadian UniversityCompletedDental Caries in ChildrenEgypt
-
TC Erciyes UniversityCompleted
Clinical Trials on Hall Technique Prefabricated Metal Crown
-
Marmara UniversityNot yet recruiting
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
Marmara UniversityNot yet recruiting
-
Primary Health Care Corporation, QatarRecruiting
-
Bahçeşehir UniversityCompletedDental Caries | Caries; DentinTurkey
-
Rambam Health Care CampusUnknown
-
University of Nove de JulhoUniversidade Metropolitana de SantosNot yet recruiting
-
Cairo UniversityUnknownSingle Tooth Dental Implant
-
Hacettepe UniversityEnrolling by invitationDental Caries | Primary Teeth | Dentin, CariousTurkey
-
Ankara Yildirim Beyazıt UniversityActive, not recruitingStomatognathic Diseases | Dental Caries in Children | Tooth Demineralization | Tooth DiseasesTurkey