Class II Dental CariesNCT06092567
Post-operative Sensitivity in Composite Restorations
A study testing Group A ( Oblique Incremental Placement Technique) and Group B (Bulk-fill Placement technique) in people with Class II Dental Caries and Sensitivity, Tooth, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Participants will be divided into groups. In group A, Composite restoration done using oblique incremental technique. In group B, Bulk-fill technique was used. VAS scoring to evaluate the primary outcome at one day, one week and two weeks. 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 Dental Caries, Sensitivity, Tooth
- What is being tested?
- Group A ( Oblique Incremental Placement Technique) and Group B (Bulk-fill Placement technique)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2022to 24 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum 18 years of age with good general health
- Vital and Periodontally stable teeth
- Class-II primary carious lesions with a cavity depth of 3 to 5 mm
- Established contact with adjacent and opposing natural or prosthetic teeth
- Prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining)
Who cannot join
- Teeth with a history of spontaneous pain
- Compromised oral health status
- Patients with parafunctional habits or temporomandibular disorders
- Previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis
- Participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 weeks
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad
About this study
Official title: Post-operative Sensitivity in Composites Using Bulk-fill vs. Oblique Incremental Placement Technique: a Double-blind, Randomized Trial
Participants will be divided into groups. In group A, Composite restoration done using oblique incremental technique. In group B, Bulk-fill technique was used. VAS scoring to evaluate the primary outcome at one day, one week and two weeks.
Read the detailed description
After the approval from ethical research committee, a written informed consent taken. Participants were briefed about the intervention with its associated merits and demerits. The restorative procedures were accomplished under rubber dam isolation using adequate local anesthesia. The principles of minimally intervention and adhesive dentistry were employed. Participants were allocated into two groups. In group A, restorative interventive was performed using Oblique incremental placement while in group B, Bulk-fill technique was used. Post-operative sensitivity was recorded at one day, one week and two week follow up using a Visual analogue scale.
- Conditions
- Class II Dental Caries, Sensitivity, Tooth
- Being tested
- Group A ( Oblique Incremental Placement Technique), Group B (Bulk-fill Placement technique)
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A ( Oblique Incremental Placement Technique)Procedure or surgery
In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.
Group B (Bulk-fill Placement technique)Procedure or surgery
In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm
| Study group | Role | What they receive |
|---|---|---|
| Group A (Oblique Incremental Placement Techniique) | Experimental | In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness. Receives: Procedure: Group A ( Oblique Incremental Placement Technique) |
| Group B (Bulk-fill Placement Technique) | Experimental | In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm. Receives: Procedure: Group B (Bulk-fill Placement technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity in composite resin restoration
Evaluation of post-restorative sensitivity in composite restorations using Visual analogue scale score with scoring from 0 to 10. Score 0 (none), 1 to 3 (mild), 4 to 6 (moderate), and 7 to 10 (severe).
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Dec 2022
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Class II Dental CariesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In this study, participants allocated in two groups by Consecutive non-random sampling technique
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NEHAL AMIR, Pakistan Institute of Medical Sciences
- Investigators
- Nehal Amir, BDS, Principal investigator, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092567
- Sponsor's protocol ID
- SOD/ERB/2022/04
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.
PubMed 31592052Tardem C, Albuquerque EG, Lopes LS, Marins SS, Calazans FS, Poubel LA, Barcelos R, Barceleiro MO. Clinical time and postoperative sensitivity after use of bulk-fill (syringe and capsule) vs. incremental filling composites: a randomized clinical trial. Braz Oral Res. 2019 Sep 16;33(0):e089. doi: 10.1590/1807-3107bor-2019.vol33.0089.
PubMed 31531552
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Sensitivity in Composites Using Bulk-fill vs. Oblique Incremental Placement Technique: a Double-blind, Randomized Trial
- ClinicalTrials.gov ID
- NCT06092567
- Acronym / sponsor ID
- SOD/ERB/2022/04
- Conditions
- Class II Dental Caries, Sensitivity, Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 23 Oct 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.
Participants will be divided into groups. In group A, Composite restoration done using oblique incremental technique. In group B, Bulk-fill technique was used. VAS scoring to evaluate the primary outcome at one day, one week and two weeks.
Detailed description
After the approval from ethical research committee, a written informed consent taken. Participants were briefed about the intervention with its associated merits and demerits. The restorative procedures were accomplished under rubber dam isolation using adequate local anesthesia. The principles of minimally intervention and adhesive dentistry were employed. Participants were allocated into two groups. In group A, restorative interventive was performed using Oblique incremental placement while in group B, Bulk-fill technique was used. Post-operative sensitivity was recorded at one day, one week and two week follow up using a Visual analogue scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, participants allocated in two groups by Consecutive non-random sampling technique
| Arm | Type | Receives |
|---|---|---|
| Group A (Oblique Incremental Placement Techniique) | Experimental | Procedure: Group A ( Oblique Incremental Placement Technique)In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness. |
| Group B (Bulk-fill Placement Technique) | Experimental | Procedure: Group B (Bulk-fill Placement technique)In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum 18 years of age with good general health
- Vital and Periodontally stable teeth
- Class-II primary carious lesions with a cavity depth of 3 to 5 mm
- Established contact with adjacent and opposing natural or prosthetic teeth
- Prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining)
Key exclusion criteria (5 listed)
- Teeth with a history of spontaneous pain
- Compromised oral health status
- Patients with parafunctional habits or temporomandibular disorders
- Previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis
- Participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 weeks
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 |
|---|---|---|
| Group A ( Oblique Incremental Placement Technique)In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness. | Procedure or surgery | Group A (Oblique Incremental Placement Techniique) |
| Group B (Bulk-fill Placement technique)In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm | Procedure or surgery | Group B (Bulk-fill Placement Technique) |
Primary outcome
Post-operative sensitivity in composite resin restoration
Time frame: Two weeks
Evaluation of post-restorative sensitivity in composite restorations using Visual analogue scale score with scoring from 0 to 10. Score 0 (none), 1 to 3 (mild), 4 to 6 (moderate), and 7 to 10 (severe).
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 23 Oct 2023.
- Background: PubMed 31592052Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.
- Background: PubMed 31531552Tardem C, Albuquerque EG, Lopes LS, Marins SS, Calazans FS, Poubel LA, Barcelos R, Barceleiro MO. Clinical time and postoperative sensitivity after use of bulk-fill (syringe and capsule) vs. incremental filling composites: a randomized clinical trial. Braz Oral Res. 2019 Sep 16;33(0):e089. doi: 10.1590/1807-3107bor-2019.vol33.0089.
- Individual participant dataSharing planned: No
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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.
Nehal Amir, BDS principal investigator
Pakistan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A ( Oblique Incremental Placement Technique) and Group B (Bulk-fill Placement technique) in people with Class II Dental Caries and Sensitivity, Tooth, 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 5 inclusion and 5 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 23 Oct 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?
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 sensitivity in composite resin restoration (time frame: Two weeks). 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 NCT06092567, which also lists 2 linked publications.
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 23 Oct 2023.