Deep Carious LesionsNCT06707311
A Comparative Study of Different Traditional and Bioactive Indirect Pulp Capping Materials
A study testing patients received calcium hydroxide with glass ionomer restorative material, patients received TheraCal LC with glass ionomer restorative material and patients received bioactive bonding with glass ionomer restorative material in people with Deep Carious Lesions and Caries Class I, run by Cairo University at 1 site in Egypt.
Trial summary
The protection of the dentin-pulp complex consists of the application of one or more layers of specific material between the restorative material and dental tissue to avoid additional challenge to the pulp tissue caused by operative procedures, toxicity of restorative materials and bacteria penetration due to… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Deep Carious Lesions, Caries Class I, Caries Class II
- What is being tested?
- patients received calcium hydroxide with glass ionomer restorative material, patients received TheraCal LC with glass ionomer restorative material and patients received bioactive bonding with glass ionomer restorative material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Oct 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient's age ranges from 20-50 years old with vital first permanent molar tooth on testing by vitality test, such as thermal or electrical pulp tester.
- Class I or II cavities.
- Deep carious lesions.
- Absence of clinical signs or symptoms suggesting non-vital tooth such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.
- Sufficient tooth structure for restoration.
- Healthy patients with good general health.
- Patients are cooperative and motivated.
Who cannot join
- Patient with systemic diseases such as uncontrolled diabetic, cardiovascular diseases, or patient received chemotherapy or radiotherapy.
- History of spontaneous, unprovoked toothache or mobility, (grade I, II and III).
- Sensitivity to percussion, external or internal root resorption, periapical lesions or presence of a fistulae.
- Pregnant females.
- Drug abuser patients.
- Previously restored teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Different Traditional and Bioactive Indirect Pulp Capping Materials on Dentin Hypersensitivity.In-vivo Study
The protection of the dentin-pulp complex consists of the application of one or more layers of specific material between the restorative material and dental tissue to avoid additional challenge to the pulp tissue caused by operative procedures, toxicity of restorative materials and bacteria penetration due to microleakage. Protection of the dentinpulp complex has also the function to recover pulp vitality.The materials that can be used for this purpose are varnishes,calcium hydroxide (CH)-based products, glass ionomer cements (GICs) and adhesive systems.The biological compatibility together with the sealing capabilities of dental materials is of paramount importance to avoid or limit pulp tissue irritation and dentinal hypersensitivity.
Read the detailed description
Pulp plays an important role in the formation and nutrition of dentin as well as in the innervation and defense of the teeth. The primary pulp function is dentin formation, which begins in the moment that the peripheric mesenchimal cells differentiate into odontoblasts and starts the deposition of collagen matrix, in a sequence of deposition/mineralization that ends with the complete tooth formation. Even after the initial formation, pulp continues to physiologically produce dentin due to the tooth aging. Reparative dentin may also be produced in response to physical and/or chemical injuries. Odontoblasts maintain their processes inside the newly formed tissue, thus creating real channels that are responsible for dentin nutrition. changes in the flow of the fluid in the dentinal tubules can trigger pain receptors present on nerve endings in the pulpal aspect to fire nerve impulses, thereby causing pain . This hydrodynamic flow can be increased by changes in temperature, humidity, air pressure and osmotic pressure, or forces acting on the tooth. Hot or cold foods and drinks, and physical pressure are typical triggers in people with dentin hypersensitivity.
- Conditions
- Deep Carious Lesions, Caries Class I, Caries Class II
- Being tested
- patients received calcium hydroxide with glass ionomer restorative material, patients received TheraCal LC with glass ionomer restorative material, patients received bioactive bonding with glass ionomer restorative material, patients received universal bonding with glass ionomer restorative material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients received calcium hydroxide with glass ionomer restorative materialOther
patients received calcium hydroxide with glass ionomer restorative material
patients received TheraCal LC with glass ionomer restorative materialOther
patients received TheraCal LC with glass ionomer restorative material
patients received bioactive bonding with glass ionomer restorative materialOther
patients received bioactive bonding with glass ionomer restorative material
patients received universal bonding with glass ionomer restorative materialOther
patients received bioactive bonding with glass ionomer restorative material
| Study group | Role | What they receive |
|---|---|---|
| patients received calcium hydroxide with resin composite | Active comparator | patients received calcium hydroxide lining material then restored with resin composite Receives: Other: patients received calcium hydroxide with glass ionomer restorative material |
| patients received TheraCal LC with resin composite | Active comparator | patients received TheraCal LC lining material then restored with resin composite Receives: Other: patients received TheraCal LC with glass ionomer restorative material |
| patients received universal bonding with resin composite | Active comparator | patients received universal bonding as lining material then restored with resin composite Receives: Other: patients received universal bonding with glass ionomer restorative material |
| patients received bioactive bonding with resin composite | Active comparator | patients received bioactive bonding as lining material then restored with resin composite Receives: Other: patients received bioactive bonding with glass ionomer restorative material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative hypersensitivity
Quantitative Assessment by using Verbal analogue scale scoring from 0 - 4 where 0 indicates no pain and 4 indicates intensifying pain
Measured: 6 month
Secondary outcomes (1)
Radiographic evaluation
Patients in all the eight groups were evaluated clinically and radiographically immediately after the procedure,1 week,1 month , 3 months and 6 months using the following criteria: (1) absence of spontaneous pain and/or sensitivity to pressure; (2) absence of sinus, fistula, edema, and/or abnormal mobility; (3) absence of radiolucency at the interradicular and/or periapical regions; (4) absence of internal or external root resorption.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Carious LesionsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Badr University
- Responsible party
- Principal investigator, Mai Salah Ibrahim Afifi Elgohary, Cairo University
- Investigators
- Ahmed A Abdelaziz, PhD, Principal investigator, BADR University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707311
- Sponsor's protocol ID
- BUC-IACUC-240623-102
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Different Traditional and Bioactive Indirect Pulp Capping Materials on Dentin Hypersensitivity.In-vivo Study
- ClinicalTrials.gov ID
- NCT06707311
- Acronym / sponsor ID
- BUC-IACUC-240623-102
- Conditions
- Deep Carious Lesions, Caries Class I, Caries Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Badr University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The protection of the dentin-pulp complex consists of the application of one or more layers of specific material between the restorative material and dental tissue to avoid additional challenge to the pulp tissue caused by operative procedures, toxicity of restorative materials and bacteria penetration due to microleakage. Protection of the dentinpulp complex has also the function to recover pulp vitality.The materials that can be used for this purpose are varnishes,calcium hydroxide (CH)-based products, glass ionomer cements (GICs) and adhesive systems.The biological compatibility together with the sealing capabilities of dental materials is of paramount importance to avoid or limit pulp tissue irritation and dentinal hypersensitivity.
Detailed description
Pulp plays an important role in the formation and nutrition of dentin as well as in the innervation and defense of the teeth. The primary pulp function is dentin formation, which begins in the moment that the peripheric mesenchimal cells differentiate into odontoblasts and starts the deposition of collagen matrix, in a sequence of deposition/mineralization that ends with the complete tooth formation. Even after the initial formation, pulp continues to physiologically produce dentin due to the tooth aging. Reparative dentin may also be produced in response to physical and/or chemical injuries. Odontoblasts maintain their processes inside the newly formed tissue, thus creating real channels that are responsible for dentin nutrition. changes in the flow of the fluid in the dentinal tubules can trigger pain receptors present on nerve endings in the pulpal aspect to fire nerve impulses, thereby causing pain . This hydrodynamic flow can be increased by changes in temperature, humidity, air pressure and osmotic pressure, or forces acting on the tooth. Hot or cold foods and drinks, and physical pressure are typical triggers in people with dentin hypersensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients received calcium hydroxide with resin composite | Active comparator | Other: patients received calcium hydroxide with glass ionomer restorative materialpatients received calcium hydroxide lining material then restored with resin composite |
| patients received TheraCal LC with resin composite | Active comparator | Other: patients received TheraCal LC with glass ionomer restorative materialpatients received TheraCal LC lining material then restored with resin composite |
| patients received universal bonding with resin composite | Active comparator | Other: patients received universal bonding with glass ionomer restorative materialpatients received universal bonding as lining material then restored with resin composite |
| patients received bioactive bonding with resin composite | Active comparator | Other: patients received bioactive bonding with glass ionomer restorative materialpatients received bioactive bonding as lining material then restored with resin composite |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient's age ranges from 20-50 years old with vital first permanent molar tooth on testing by vitality test, such as thermal or electrical pulp tester.
- Class I or II cavities.
- Deep carious lesions.
- Absence of clinical signs or symptoms suggesting non-vital tooth such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.
- Sufficient tooth structure for restoration.
Key exclusion criteria (6 listed)
- Patient with systemic diseases such as uncontrolled diabetic, cardiovascular diseases, or patient received chemotherapy or radiotherapy.
- History of spontaneous, unprovoked toothache or mobility, (grade I, II and III).
- Sensitivity to percussion, external or internal root resorption, periapical lesions or presence of a fistulae.
- Pregnant females.
- Drug abuser patients.
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 |
|---|---|---|
| patients received calcium hydroxide with glass ionomer restorative materialpatients received calcium hydroxide with glass ionomer restorative material | Other | patients received calcium hydroxide with resin composite |
| patients received TheraCal LC with glass ionomer restorative materialpatients received TheraCal LC with glass ionomer restorative material | Other | patients received TheraCal LC with resin composite |
| patients received bioactive bonding with glass ionomer restorative materialpatients received bioactive bonding with glass ionomer restorative material | Other | patients received bioactive bonding with resin composite |
| patients received universal bonding with glass ionomer restorative materialpatients received bioactive bonding with glass ionomer restorative material | Other | patients received universal bonding with resin composite |
Primary outcome
Post operative hypersensitivity
Time frame: 6 month
Quantitative Assessment by using Verbal analogue scale scoring from 0 - 4 where 0 indicates no pain and 4 indicates intensifying pain
1 secondary outcome
Radiographic evaluation
Time frame: 6 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 27 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Deep Carious Lesions
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Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
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Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
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A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
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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.
Ahmed A Abdelaziz, PhD principal investigator
BADR University in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients received calcium hydroxide with glass ionomer restorative material, patients received TheraCal LC with glass ionomer restorative material and patients received bioactive bonding with glass ionomer restorative material in people with Deep Carious Lesions and Caries Class I, 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 7 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: finished, as of the sponsor's last update on 27 Nov 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 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?
Post operative hypersensitivity (time frame: 6 month). 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 27 Nov 2024.