Class II Caries in Posterior TeethNCT05414656
A Clinical Trial of Composite Class II Restorations With Two Different Matrix Bands
A study testing Saddle contoured metal matrix, Pre-contoured self-adhesive matrix in people with Class II Caries in Posterior Teeth, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Class II Caries in Posterior Teeth
- What is being tested?
- Saddle contoured metal matrix, Pre-contoured self-adhesive matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2022to Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Permanent fully erupted teeth with class II supra-gingival caries or the necessity of replacing class II restoration.
- The patient who has adjacent teeth available for the contact with surrounding tooth structure.
- Teeth with cavity isthmus less than one-third of inter-cuspal distance
Who cannot join
- • Partially erupted or deciduous teeth.
- Teeth with orthodontic bands or brackets.
- 3rd Molar and rotated teeth.
- Teeth with dental caries extending up to pulp with periapical pathosis or periodontally weak teeth.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
Islamabad, Islamabad
About this study
Official title: Comparison of Saddle Contoured Metal Matrix and Pre-contoured Self-adhesive Matrix in Composite Resin Class II Restorations
Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables.
Read the detailed description
A total of 60 posterior teeth with proximal cavity to be assigned on alternate basis in two equal groups. Group A teeth received the Saddle contoured metal matrix and group B pre-contoured self-adhesive matrix after cavity preparation.
All teeth to be restored with Nano hybrid composite restorative material. Outcome of proximal contours and contact tightness is determined by a blinded assessor just after the restoration.
- Conditions
- Class II Caries in Posterior Teeth
- Being tested
- Saddle contoured metal matrix, Pre-contoured self-adhesive matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saddle contoured metal matrix, Pre-contoured self-adhesive matrixDevice
Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.
| Study group | Role | What they receive |
|---|---|---|
| Group A : Saddle contoured metal matrix | Experimental | The prepared teeth received the Saddle contoured metal matrix. The saddle clip of matrix connect the band and secured around prepared cavity wall. The anatomical wedge placed into the gingival embrasure to maintain the height of gingival floor and ensure the optimal adaptation of the matrix band in the cervical region. Receives: Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix |
| Group B:pre-contoured self-adhesive matrix | Active comparator | Teeth received the Pre-contoured self adhesive matrix with anatomical wedges. The adhesive end of band closed around the prepared cavity. Receives: Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
proximal contacts tightness
The tightness of the proximal contact area resulting from Saddle contoured metal matrix and pre-contoured self-adhesive matrix . It was measured using a nine inch long nylon dental floss (Oral-B, USA).
Measured: immediately after procedure
Secondary outcomes (1)
Proximal contours and overhangs
To be examined clinically with an explorer and mouth mirror and then on the radiograph by the blinded co investigator.
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start2 May 2022
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II Caries in Posterior TeethStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, nosheen sarwar, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414656
- Sponsor's protocol ID
- SOD/ERB/2022/02
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarwar N, Khokhar SA. Comparison of saddle contoured metal matrix and pre-contoured self-adhesive matrix in composite resin class II restorations; an in vivo study. J Pak Med Assoc. 2024 Feb;74(2):209-215. doi: 10.47391/JPMA.8627.
PubMed 38419215
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Saddle Contoured Metal Matrix and Pre-contoured Self-adhesive Matrix in Composite Resin Class II Restorations
- ClinicalTrials.gov ID
- NCT05414656
- Acronym / sponsor ID
- SOD/ERB/2022/02
- Conditions
- Class II Caries in Posterior Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 2 May 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 10 Jun 2022 (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.
Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables.
Detailed description
A total of 60 posterior teeth with proximal cavity to be assigned on alternate basis in two equal groups. Group A teeth received the Saddle contoured metal matrix and group B pre-contoured self-adhesive matrix after cavity preparation.
All teeth to be restored with Nano hybrid composite restorative material. Outcome of proximal contours and contact tightness is determined by a blinded assessor just after the restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Saddle contoured metal matrix | Experimental | Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrixThe prepared teeth received the Saddle contoured metal matrix. The saddle clip of matrix connect the band and secured around prepared cavity wall. The anatomical wedge placed into the gingival embrasure to maintain the height of gingival floor and ensure the optimal adaptation of the matrix band in the cervical region. |
| Group B:pre-contoured self-adhesive matrix | Active comparator | Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrixTeeth received the Pre-contoured self adhesive matrix with anatomical wedges. The adhesive end of band closed around the prepared cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Permanent fully erupted teeth with class II supra-gingival caries or the necessity of replacing class II restoration.
Key exclusion criteria (4 listed)
- • Partially erupted or deciduous teeth.
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 |
|---|---|---|
| Saddle contoured metal matrix, Pre-contoured self-adhesive matrixSaddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability. | Device | Group A : Saddle contoured metal matrix, Group B:pre-contoured self-adhesive matrix |
Primary outcome
proximal contacts tightness
Time frame: immediately after procedure
The tightness of the proximal contact area resulting from Saddle contoured metal matrix and pre-contoured self-adhesive matrix . It was measured using a nine inch long nylon dental floss (Oral-B, USA).
1 secondary outcome
Proximal contours and overhangs
Time frame: immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 38419215Sarwar N, Khokhar SA. Comparison of saddle contoured metal matrix and pre-contoured self-adhesive matrix in composite resin class II restorations; an in vivo study. J Pak Med Assoc. 2024 Feb;74(2):209-215. doi: 10.47391/JPMA.8627.
- Individual participant dataSharing planned: No
Related trials for Class II Caries in Posterior Teeth
Active, not recruiting
Clinical Evaluation of Ceramage Inlays Cemented With Beautilink Self-Adhesive Resin Cement Versus Rely X Resin Cement in Carious Posterior Teeth
Caries Class Ii
Not yet recruiting
Comparison of the Functional Properties of Two Injectable Materials in Posterior Teeth: Randomized Clinical Trial
Class II Dental Caries, Dental Caries
Not yet recruiting
Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition
Dental Caries
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 Saddle contoured metal matrix, Pre-contoured self-adhesive matrix in people with Class II Caries in Posterior Teeth, 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 3 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: status not confirmed, as of the sponsor's last update on 10 Jun 2022. 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 Nosheen Sarwar, BDS (+923088895652, nosheensarwar48@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proximal contacts tightness (time frame: immediately after procedure). 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 NCT05414656, which also lists 1 linked publication.
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 10 Jun 2022.