Deep CariesNCT03885271
Outcomes of the Hall Technique and Conventional Pulp Therapy for the Management of Caries in Primary Molars
A study testing Hall Technique and Formecresol Pulpotomy in people with Deep Caries and Pulpitis - Reversible, run by Cairo University at 1 site in Egypt.
Trial summary
Based on the changing understanding of carious biofilm development and caries progression, Sealing carious dentine beneath a restoration deprives the caries biofilm of nutrients and alters the environment sufficiently to slow or arrest lesion progression. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries, Pulpitis - Reversible
- What is being tested?
- Hall Technique and Formecresol Pulpotomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Aug 2021
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:Aged 5 to 7 years, in good general health and medically free.The parents provided a written informed consent.
- Primary molar with deep dentin caries involving occlusal and or occluso proximal surfaces.
- Vital pulp with absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
- Absence of clinical swelling or pus exaudate or fistula of soft or periodontal tissues.
- Absence of abnormal tooth mobility
- Absence of pain on percussion
Who cannot join
- Patients experience any signs or symptoms of pulpal or periapical pathology.
- Patients with systemic diseases requiring special dental consideration.
- Unmotivated uncooperative patients.
- Patients unable to attend follow up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of the Hall Technique and Conventional Pulp Therapy for the Management of Caries in Primary Molars: a Randomized Clinical Trial
Based on the changing understanding of carious biofilm development and caries progression, Sealing carious dentine beneath a restoration deprives the caries biofilm of nutrients and alters the environment sufficiently to slow or arrest lesion progression. This has the added benefit of avoiding pulp exposure and subsequent treatment .The evidence base supporting the biological approaches which include Hall technique has been steadily increasing in the last few years. This has given rise to a growing trend towards a biological approach by Paediatric dentists and has led to an increasing concern about the merits of conventional approach in treatment of carious primary molars .
Read the detailed description
In orofacial development of the child, preservation of the primary dentition for as long as possible is of great importance. As primary teeth maintain arch length and preserve masticatory function. Unfortunately, the occurrence of cavitated caries lesions is still a problem in developed and developing countries, with an increasing prevalence, particulary in developing communities, conflicting with a general descending trend in prevalence worldwide.
The management of carious primary molars in children is problematic, additionally, primary teeth commonly remain unrestored, especially in the younger children,The high levels of dental disease in primary teeth, and its inadequate management, remains a major public health issue for children, and one with a significant impact on their lives. In addition many children are having to accept toothache as a part of their childhood. Set against this background, there would seem to be some scope for the investigation of alternative approaches to the management of carious primary teeth. If an alternative technique was found to be simpler and more acceptable to children, their parents and general dental practitioners than the conventional restorative approach, yet just as effective, then it might be more readily applied in the general practice setting.
A novel, simplified method of using stainless steel crwons, the Hall Technique, has been investigated. According to American Academy of Pediatric Dentistry, Hall technique calls for cementation of a Stainless steel crown over a caries-affected primary molar without local anesthetic, caries removal or tooth preparation, This technique was developed for use when delivery of ideal treatment wasn't feasible.
As the crown is fitted with no occlusal reduction in the Hall technique, it was observed in several studies that the occlusion would has been temporarily opened and returned to the pretreatment situation within 2 weeks and no child reported Tempromandibular joint pain. This goes in accordance with the study of Innes et al., as they stated that after placement of stainless steel crowns using the Hall technique, the occlusion returns to the pretreatment situation within 15-30 days. Also, Dr. Hall stated that the occlusion tended to equilibrate by the next recall appointment and none of her patients reported Tempromandibular joint pain.
A published data from Dr Hall's practice records has indicated that Hall technique might have similar survival rates to other, more conventional, restorative options currently being used in Primary Care. In addition, avoiding the use of Local anesthesia and rotary instruments for tooth preparation and caries removal might mean that the technique is less demanding of both children and their dental team. The technique is therefore minimally invasive and can be expected to cause less discomfort than conventional treatment approaches. This aspect could be a considerable advantage as the Hall technique is a child centered approach and it is not surprising that the first data published on patient perceptions of the hall technique are promising. It was reported a clear difference in levels of discomfort, subjectively assessed by the operators, between the Hall technique and a conventional treatment approach. The Hall stainless steel crowns caused 'no discomfort' to 'mild discomfort' in comparison to the conventional restorations. Several conducted studies showed that the majority of the children, their caretakers and dentists expressed a preference for the Hall technique to the conventional restorations.
The Hall Technique embraces changing concepts of managing dental caries, moving from the dogma requiring its complete surgical excision, even at the expense of cavity size and pulpal health, to the understanding that caries in dentine can be slowed, arrested, and possibly even reversed, within a meticulously sealed environment. It is known that the microflora in sealed carious dentine changes, with the predominating organisms no longer being cariogenic having been sealed from the oral environment. This may be important in the apparent arrest of caries progression.
Owing to its non invasive design, acceptance by patients and rate of restoration longevity, the Hall technique maybe an improved treatment option to increase access to care, decrease rates of untreated caries and provide a restoration that will allow for natural tooth exfoliation.
In the last few years, conventional restorations including complete removal of carious tissue with or without pulp therapy for the treatment of carious lesions in primary teeth have been challenged and a more biological approach has been suggested. This has given rise to a growing trend towards a biological approach by paediatric dentists and has led to an increasing concern about the merits of the conventional approach and whether to retain this treatment modality as the standard technique in restoring primary teeth or to adopt the biological approach as the treatment norm.
- Conditions
- Deep Caries, Pulpitis - Reversible
- Being tested
- Hall Technique, Formecresol Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall TechniqueOther
The Hall technique is a simplified method of utilizing stainless steel crowns in treatment of carious primary molars. The SSC is cemented onto the carious tooth using glass ionomer cement. Since there is no need for carious lesion removal, the use of local anesthesia is not mandate
Formecresol PulpotomyOther
Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health .This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, Complete caries removal and then access to the pulp chamber using drills
| Study group | Role | What they receive |
|---|---|---|
| Group A (Experimental group) Hall Technique | Experimental | Clinical examination to assess the clinical inclusion criteria. Radiographic examination.The child will be positioned upright in the dental chair . The correct size of PMC for the tooth will be selected. The tooth will be rinsed and dried, and the PMC dried. The PMC will be filled with glass ionomer luting cement. The PMC will be placed evenly over the tooth and the child instructed to bite down firmly until the crown was pushed down over the tooth;If the child was unable or unwilling to bite down on the PMC, finger pressure will be used to seat the crown Extruded cement will be removed, and the child will be asked to keep biting on the Hall PMC until the cement sets and once cement sets, excess cement is removed, floss will be used to clear the aproximal contacts, and post-fitting instructions will be given (Innes et al. 2007). Receives: Other: Hall Technique |
| Group B (control group) Formecresol Pulpotomy | Active comparator | Clinical examination to assess the clinical inclusion criteria. Radiographic examination. The teeth anesthetized, rubber dam isolation, Complete caries removal achieved with a sterile round steel bur in a slow- speed handpiece. Access to the pulp chamber performed using a sterile slow-speed round steel bur. The pulp amputation with a sterile diamond bur in a high-speed handpiece and pulpal debris removed with a sterile saline solution on a sterile cotton pledget. After pulp amputation haemostasis achieved using a sterile cotton pledget. Formocresol (FC) applied using a sterile cotton pledget for 5 minutes. After removal of the formocresol soaked cotton pledget, the pulp chamber rinsed with water using an air-water syringe. The pulp chamber dried with a sterile cotton pledget, followed by application of Zinc Oxide \& Eugenol and zinc phosphate. Tooth preparation done to receive stainless steel crown. Receives: Other: Formecresol Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain reported by the patient after pulpotomy and Hall Technique
Postoperative pain reported by the patient after pulpotomy and Hall Technique using visual analogue scale .Scale from 0 to 9. (Point 0): No pain ,(Points 1-3): mild pain,(Points 4-6):moderate pain, (7-9): severe pain
Measured: 10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 May 2020
- Primary completion15 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa AbdEl Moniem, Cairo University
- Investigators
- Hanaa A Ibraheem, MsD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885271
- Sponsor's protocol ID
- CEBD-CU-2019-03-16
- Status last verified
- Sep 2021
- First submitted
- 16 Mar 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Informed consent form, clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of the Hall Technique and Conventional Pulp Therapy for the Management of Caries in Primary Molars: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03885271
- Acronym / sponsor ID
- CEBD-CU-2019-03-16
- Conditions
- Deep Caries, Pulpitis - Reversible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 21 Mar 2019 (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.
Based on the changing understanding of carious biofilm development and caries progression, Sealing carious dentine beneath a restoration deprives the caries biofilm of nutrients and alters the environment sufficiently to slow or arrest lesion progression. This has the added benefit of avoiding pulp exposure and subsequent treatment .The evidence base supporting the biological approaches which include Hall technique has been steadily increasing in the last few years. This has given rise to a growing trend towards a biological approach by Paediatric dentists and has led to an increasing concern about the merits of conventional approach in treatment of carious primary molars .
Detailed description
In orofacial development of the child, preservation of the primary dentition for as long as possible is of great importance. As primary teeth maintain arch length and preserve masticatory function. Unfortunately, the occurrence of cavitated caries lesions is still a problem in developed and developing countries, with an increasing prevalence, particulary in developing communities, conflicting with a general descending trend in prevalence worldwide.
The management of carious primary molars in children is problematic, additionally, primary teeth commonly remain unrestored, especially in the younger children,The high levels of dental disease in primary teeth, and its inadequate management, remains a major public health issue for children, and one with a significant impact on their lives. In addition many children are having to accept toothache as a part of their childhood. Set against this background, there would seem to be some scope for the investigation of alternative approaches to the management of carious primary teeth. If an alternative technique was found to be simpler and more acceptable to children, their parents and general dental practitioners than the conventional restorative approach, yet just as effective, then it might be more readily applied in the general practice setting.
A novel, simplified method of using stainless steel crwons, the Hall Technique, has been investigated. According to American Academy of Pediatric Dentistry, Hall technique calls for cementation of a Stainless steel crown over a caries-affected primary molar without local anesthetic, caries removal or tooth preparation, This technique was developed for use when delivery of ideal treatment wasn't feasible.
As the crown is fitted with no occlusal reduction in the Hall technique, it was observed in several studies that the occlusion would has been temporarily opened and returned to the pretreatment situation within 2 weeks and no child reported Tempromandibular joint pain. This goes in accordance with the study of Innes et al., as they stated that after placement of stainless steel crowns using the Hall technique, the occlusion returns to the pretreatment situation within 15-30 days. Also, Dr. Hall stated that the occlusion tended to equilibrate by the next recall appointment and none of her patients reported Tempromandibular joint pain.
A published data from Dr Hall's practice records has indicated that Hall technique might have similar survival rates to other, more conventional, restorative options currently being used in Primary Care. In addition, avoiding the use of Local anesthesia and rotary instruments for tooth preparation and caries removal might mean that the technique is less demanding of both children and their dental team. The technique is therefore minimally invasive and can be expected to cause less discomfort than conventional treatment approaches. This aspect could be a considerable advantage as the Hall technique is a child centered approach and it is not surprising that the first data published on patient perceptions of the hall technique are promising. It was reported a clear difference in levels of discomfort, subjectively assessed by the operators, between the Hall technique and a conventional treatment approach. The Hall stainless steel crowns caused 'no discomfort' to 'mild discomfort' in comparison to the conventional restorations. Several conducted studies showed that the majority of the children, their caretakers and dentists expressed a preference for the Hall technique to the conventional restorations.
The Hall Technique embraces changing concepts of managing dental caries, moving from the dogma requiring its complete surgical excision, even at the expense of cavity size and pulpal health, to the understanding that caries in dentine can be slowed, arrested, and possibly even reversed, within a meticulously sealed environment. It is known that the microflora in sealed carious dentine changes, with the predominating organisms no longer being cariogenic having been sealed from the oral environment. This may be important in the apparent arrest of caries progression.
Owing to its non invasive design, acceptance by patients and rate of restoration longevity, the Hall technique maybe an improved treatment option to increase access to care, decrease rates of untreated caries and provide a restoration that will allow for natural tooth exfoliation.
In the last few years, conventional restorations including complete removal of carious tissue with or without pulp therapy for the treatment of carious lesions in primary teeth have been challenged and a more biological approach has been suggested. This has given rise to a growing trend towards a biological approach by paediatric dentists and has led to an increasing concern about the merits of the conventional approach and whether to retain this treatment modality as the standard technique in restoring primary teeth or to adopt the biological approach as the treatment norm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Experimental group) Hall Technique | Experimental | Other: Hall TechniqueClinical examination to assess the clinical inclusion criteria. Radiographic examination.The child will be positioned upright in the dental chair . The correct size of PMC for the tooth will be selected. The tooth will be rinsed and dried, and the PMC dried. The PMC will be filled with glass ionomer luting cement. The PMC will be placed evenly over the tooth and the child instructed to bite down firmly until the crown was pushed down over the tooth;If the child was unable or unwilling to bite down on the PMC, finger pressure will be used to seat the crown Extruded cement will be removed, and the child will be asked to keep biting on the Hall PMC until the cement sets and once cement sets, excess cement is removed, floss will be used to clear the aproximal contacts, and post-fitting instructions will be given (Innes et al. 2007). |
| Group B (control group) Formecresol Pulpotomy | Active comparator | Other: Formecresol PulpotomyClinical examination to assess the clinical inclusion criteria. Radiographic examination. The teeth anesthetized, rubber dam isolation, Complete caries removal achieved with a sterile round steel bur in a slow- speed handpiece. Access to the pulp chamber performed using a sterile slow-speed round steel bur. The pulp amputation with a sterile diamond bur in a high-speed handpiece and pulpal debris removed with a sterile saline solution on a sterile cotton pledget. After pulp amputation haemostasis achieved using a sterile cotton pledget. Formocresol (FC) applied using a sterile cotton pledget for 5 minutes. After removal of the formocresol soaked cotton pledget, the pulp chamber rinsed with water using an air-water syringe. The pulp chamber dried with a sterile cotton pledget, followed by application of Zinc Oxide \& Eugenol and zinc phosphate. Tooth preparation done to receive stainless steel crown. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children:Aged 5 to 7 years, in good general health and medically free.The parents provided a written informed consent.
- Primary molar with deep dentin caries involving occlusal and or occluso proximal surfaces.
- Vital pulp with absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
- Absence of clinical swelling or pus exaudate or fistula of soft or periodontal tissues.
- Absence of abnormal tooth mobility
Key exclusion criteria (4 listed)
- Patients experience any signs or symptoms of pulpal or periapical pathology.
- Patients with systemic diseases requiring special dental consideration.
- Unmotivated uncooperative patients.
- Patients unable to attend follow up visits.
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 TechniqueThe Hall technique is a simplified method of utilizing stainless steel crowns in treatment of carious primary molars. The SSC is cemented onto the carious tooth using glass ionomer cement. Since there is no need for carious lesion removal, the use of local anesthesia is not mandate | Other | Group A (Experimental group) Hall Technique |
| Formecresol PulpotomyPulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health .This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, Complete caries removal and then access to the pulp chamber using drills | Other | Group B (control group) Formecresol Pulpotomy |
Primary outcome
Postoperative pain reported by the patient after pulpotomy and Hall Technique
Time frame: 10 days postoperatively
Postoperative pain reported by the patient after pulpotomy and Hall Technique using visual analogue scale .Scale from 0 to 9. (Point 0): No pain ,(Points 1-3): mild pain,(Points 4-6):moderate pain, (7-9): severe pain
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 21 Sep 2021.
- Individual participant dataSharing planned: Yes. Study Protocol, Informed consent form, clinical study report
Related trials for Deep Caries
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Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
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Moderate Severe Pulpitis, Extremely Deep Caries
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
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.
Hanaa A Ibraheem, MsD principal investigator
Cairo University
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 and Formecresol Pulpotomy in people with Deep Caries and Pulpitis - Reversible, 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 6 inclusion and 4 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 21 Sep 2021. 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?
Postoperative pain reported by the patient after pulpotomy and Hall Technique (time frame: 10 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.