Tooth DecayNCT05734027
COMPARISON OF SECTIONAL MATRIX VERSUES CIRCUMFERENTIAL MATRIX FOR RECONSTRUCTION OF PROXIMAL CONTACT IN CLASS 2 RESTORATIONS
A study testing Sectional matrix and Circumferential matrix in people with Tooth Decay, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Class II caries affects proximal surfaces of premolars and maintain their anatomical proximal contact of tooth, is important to avoid food impaction in the interdental area for protection of periodontium and occurrence of secondary carious lesion.Different types of Matrix band system are used to restore tooth cavities… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Decay
- What is being tested?
- Sectional matrix and Circumferential matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Aug 2022to 10 Mar 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Tooth with compound class 2 cavities Patient with good general health. Patient with minimum age of 18 years. Fully erupted occluding premolar and molar teeth.
Who cannot join
- Tooth complex class 2 cavities. Tooth with severe periodontal disease. Diastema between posterior teeth. Third molars are excluded.
- . Tooth mobility greater than 1 mm.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pims ,school of dentistry
Islamabad, 04403
Sheejia Asif, BDS, 03165518512, sheejiaasif@gmail.com
Aqsa waheed, BDS, 03063422518, q.aqsa@rocketmail.com
About this study
Class II caries affects proximal surfaces of premolars and maintain their anatomical proximal contact of tooth, is important to avoid food impaction in the interdental area for protection of periodontium and occurrence of secondary carious lesion.Different types of Matrix band system are used to restore tooth cavities with missing proximal walls, including flat or pre-contoured bands, retainer-fixed circumferential systems, and sectional matrices, and either metal or plastic matrices which produces good contours and contacts for use with amalgam and can also be employed for insertion of composite resin.This study aimed at assessing the influence of different matricing techniques :either sectional matrix or circumferential matrix and the influence of operator experience on reproduction of optimum proximal contacts for posterior proximal resin composite restorations.
Read the detailed description
Local anesthesia will be administrated, and the whole quadrant containing the offending tooth will be isolated by using a rubber dam.After caries removal and cavity preparation, matrix systems will be applied by dentist ; using either a sectional matrix system and circumferential matrix system.A properly sized wedge will be used with both systems to secure both matrices in place cervically and to prevent gingival overhangs , Resin composite restorations will be completed according to the manufacturer's instructions. Selective enamel etching will be performed by using etchant followed by applying Single Bond Universal adhesive to the entire surface of the enamel and dentin. Then, a thin layer of flowable composite will be applied to ensure adaptation at the gingival margin. Finally, prepared cavities will be restored by using resin composite. using the centripetal technique to build a proximal wall initially followed by successive cusp building. Restorations will be finished by using a flame-shaped finishing stone and polished, and the occlusal contact points will be checked by using a articulating paper. Tightness of proximal contacts will be evaluated using dental floss . For assessment of the restoration, the patients will be sitting in a dental unit with a standardized seating position, which will be reproduced by the unit's preset positioning system, and assessors evaluated the proximal contact by using unwaxed dental floss following theFDI recommendations accordingly to be either optimum, tight, or open contact.Proximal contacts will be categorized as optimum, open, and tight; if the dental floss passed through the contact area as natural dentition on the other side, it will be considered as an optimum contact point. Open contact points will be considered when the dental floss passed through the contact area without resistance; however, when the dental floss could not be passed at all or tore, proximal contact will be considered as tight.
- Conditions
- Tooth Decay
- Being tested
- Sectional matrix, Circumferential matrix
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sectional matrixDevice
The sectional matrix is the best way to achieve a strong contact point in Class II restorations with composite resin in the posterior dental sector. The pre-wedging is essential to get a separation between teeth which avoid the matrix deformation during its insertion
Circumferential matrixDevice
Circumferential matrix (thickness 0.038mm) ,the band encircle the tooth and secured by retainer on the buccal and lingual aspect
| Study group | Role | What they receive |
|---|---|---|
| Sectional matrix band | Experimental | precontoured sectional matrix band Receives: Device: Sectional matrix; Device: Circumferential matrix |
| Circumferential matrix band | Active comparator | Circumferential matrix band applied by tofflemire retainer Receives: Device: Sectional matrix; Device: Circumferential matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tightness of proximal contact
Proximal contact either optimum, tight, or open contact by using dental floss
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start27 Aug 2022
- Primary completion2 Mar 2023 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, sheejia asif, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734027
- Sponsor's protocol ID
- SOD/ERB/2023/18
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- 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 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF SECTIONAL MATRIX VERSUES CIRCUMFERENTIAL MATRIX FOR RECONSTRUCTION OF PROXIMAL CONTACT IN CLASS 2 RESTORATIONS
- ClinicalTrials.gov ID
- NCT05734027
- Acronym / sponsor ID
- SOD/ERB/2023/18
- Conditions
- Tooth Decay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 27 Aug 2022 (actual)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 17 Feb 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.
Class II caries affects proximal surfaces of premolars and maintain their anatomical proximal contact of tooth, is important to avoid food impaction in the interdental area for protection of periodontium and occurrence of secondary carious lesion.Different types of Matrix band system are used to restore tooth cavities with missing proximal walls, including flat or pre-contoured bands, retainer-fixed circumferential systems, and sectional matrices, and either metal or plastic matrices which produces good contours and contacts for use with amalgam and can also be employed for insertion of composite resin.This study aimed at assessing the influence of different matricing techniques :either sectional matrix or circumferential matrix and the influence of operator experience on reproduction of optimum proximal contacts for posterior proximal resin composite restorations.
Detailed description
Local anesthesia will be administrated, and the whole quadrant containing the offending tooth will be isolated by using a rubber dam.After caries removal and cavity preparation, matrix systems will be applied by dentist ; using either a sectional matrix system and circumferential matrix system.A properly sized wedge will be used with both systems to secure both matrices in place cervically and to prevent gingival overhangs , Resin composite restorations will be completed according to the manufacturer's instructions. Selective enamel etching will be performed by using etchant followed by applying Single Bond Universal adhesive to the entire surface of the enamel and dentin. Then, a thin layer of flowable composite will be applied to ensure adaptation at the gingival margin. Finally, prepared cavities will be restored by using resin composite. using the centripetal technique to build a proximal wall initially followed by successive cusp building. Restorations will be finished by using a flame-shaped finishing stone and polished, and the occlusal contact points will be checked by using a articulating paper. Tightness of proximal contacts will be evaluated using dental floss . For assessment of the restoration, the patients will be sitting in a dental unit with a standardized seating position, which will be reproduced by the unit's preset positioning system, and assessors evaluated the proximal contact by using unwaxed dental floss following theFDI recommendations accordingly to be either optimum, tight, or open contact.Proximal contacts will be categorized as optimum, open, and tight; if the dental floss passed through the contact area as natural dentition on the other side, it will be considered as an optimum contact point. Open contact points will be considered when the dental floss passed through the contact area without resistance; however, when the dental floss could not be passed at all or tore, proximal contact will be considered as tight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sectional matrix band | Experimental | Device: Sectional matrix, Device: Circumferential matrixprecontoured sectional matrix band |
| Circumferential matrix band | Active comparator | Device: Sectional matrix, Device: Circumferential matrixCircumferential matrix band applied by tofflemire retainer |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Tooth with compound class 2 cavities Patient with good general health. Patient with minimum age of 18 years. Fully erupted occluding premolar and molar teeth.
Key exclusion criteria (2 listed)
- Tooth complex class 2 cavities. Tooth with severe periodontal disease. Diastema between posterior teeth. Third molars are excluded.
- . Tooth mobility greater than 1 mm.
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 |
|---|---|---|
| Sectional matrixThe sectional matrix is the best way to achieve a strong contact point in Class II restorations with composite resin in the posterior dental sector. The pre-wedging is essential to get a separation between teeth which avoid the matrix deformation during its insertion | Device | Circumferential matrix band, Sectional matrix band |
| Circumferential matrixCircumferential matrix (thickness 0.038mm) ,the band encircle the tooth and secured by retainer on the buccal and lingual aspect | Device | Circumferential matrix band, Sectional matrix band |
Primary outcome
Tightness of proximal contact
Time frame: immediately after the procedure
Proximal contact either optimum, tight, or open contact by using dental floss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Tooth Decay
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sectional matrix and Circumferential matrix in people with Tooth Decay, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sheejia Asif, Bds (03165518512, sheejiaasif344@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tightness of proximal contact (time frame: immediately after the procedure). 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 17 Feb 2023.