Post-Operative HypersensitivityNCT07041424
Effects of Rebonding Technique and Final Cure in Post-operative Hypersensitivity in Class 1 Composite Restorations
A study testing treatment group 1: total etch bonding agent used with rebonding technique and treatment group 2: self etch bonding agent used with rebonding technique in people with Post-Operative Hypersensitivity, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Rebonding technique has been suggested to address the issue of post-operative hypersensitivity in composite restorations. it involves the application of bonding agent on composite restoration following finishing and polishing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Hypersensitivity
- What is being tested?
- treatment group 1: total etch bonding agent used with rebonding technique and treatment group 2: self etch bonding agent used with rebonding technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- class 1 carious lesion in premolar and molars clinically diagnosed as moderate occlusal caries extending up to middle third of dentin no caries on any other surface of tooth patients with sign and symptom of reversible pulpitis like sharp pain, sensitivity to hot and cold and sweet stimuli lasting foe few seconds
Who cannot join
- history of generalized sensitivity cavities extending up to pulpal third of dentin cavities need to be restored with direct or indirect pulp capping poor oral hygiene or periodontal disease bruxism and other wear facets chronic anti inflammatory, analgesics or psychotropic drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Rebonding Technique and Final Cure on Post-Operative Hypersensitivity in Class 1 Composite Restorations
Rebonding technique has been suggested to address the issue of post-operative hypersensitivity in composite restorations. it involves the application of bonding agent on composite restoration following finishing and polishing.
Read the detailed description
Rebonding technique has been suggested to address the issue of post-operative hypersensitivity in composite restorations. it involves the application of bonding agent on composite restoration following finishing and polishing. bonding agent fills the gap formed by polymerization shrinkage and hence prevent post-operative hypersensitivity
- Conditions
- Post-Operative Hypersensitivity
- Being tested
- treatment group 1: total etch bonding agent used with rebonding technique, treatment group 2: self etch bonding agent used with rebonding technique
- Keywords
- Rebonding Technique, Post-Operative Hypersensitivity, Composite Restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment group 1: total etch bonding agent used with rebonding techniqueProcedure or surgery
class 1 composite restoration is done using total etch type bonding agent and rebonding technique applied
treatment group 2: self etch bonding agent used with rebonding techniqueProcedure or surgery
class 1 composite restoration is done using self etch type bonding agent and rebonding technique applied
| Study group | Role | What they receive |
|---|---|---|
| control group 1: total etch bonding agent without rebonding | Other | composite restoration carried out using total etch bonding agent and no rebonding technique is done Receives: Procedure: treatment group 1: total etch bonding agent used with rebonding technique |
| Control group 2: self etch bonding agent without rebonding | Other | composite restoration carried out using self etch bonding agent and no rebonding technique is done Receives: Procedure: treatment group 2: self etch bonding agent used with rebonding technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hypersensitivity
Numeric pain intensity scale 0= no sensitivity 1-3= mild sensitivity 4-6= moderate sensitivity 10=worst possible sensitivity
Measured: from treatment to 24 hours and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 May 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Oct 2025 (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 Post-Operative HypersensitivityStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- four groups. 2 control groups and 2 treatment groups. In group 1, total etch type bonding agent used but no rebonding done. In group 2, total etch bonding agent used and rebonding technique carried out. In group 3, self etch type bonding agent used but no rebonding done. in group 4, self etch bonding agent used and rebonding technique carried out.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041424
- Sponsor's protocol ID
- FUCDOP2501
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tekce N, Demirci M, Gokturk SA, Tuncer S, Ozel E, Pala K, Baydemir C. The effect of bonding and surface sealant application on postoperative sensitivity from posterior composites. J Istanb Univ Fac Dent. 2015 Oct 21;49(3):1-10. doi: 10.17096/jiufd.33921. eCollection 2015.
PubMed 28955539
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rebonding Technique and Final Cure on Post-Operative Hypersensitivity in Class 1 Composite Restorations
- ClinicalTrials.gov ID
- NCT07041424
- Acronym / sponsor ID
- FUCDOP2501
- Conditions
- Post-Operative Hypersensitivity
- Keywords
- Rebonding Technique, Post-Operative Hypersensitivity, Composite Restorations
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 27 Jun 2025 (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.
Rebonding technique has been suggested to address the issue of post-operative hypersensitivity in composite restorations. it involves the application of bonding agent on composite restoration following finishing and polishing.
Detailed description
Rebonding technique has been suggested to address the issue of post-operative hypersensitivity in composite restorations. it involves the application of bonding agent on composite restoration following finishing and polishing. bonding agent fills the gap formed by polymerization shrinkage and hence prevent post-operative hypersensitivity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- four groups. 2 control groups and 2 treatment groups. In group 1, total etch type bonding agent used but no rebonding done. In group 2, total etch bonding agent used and rebonding technique carried out. In group 3, self etch type bonding agent used but no rebonding done. in group 4, self etch bonding agent used and rebonding technique carried out.
| Arm | Type | Receives |
|---|---|---|
| control group 1: total etch bonding agent without rebonding | Other | Procedure: treatment group 1: total etch bonding agent used with rebonding techniquecomposite restoration carried out using total etch bonding agent and no rebonding technique is done |
| Control group 2: self etch bonding agent without rebonding | Other | Procedure: treatment group 2: self etch bonding agent used with rebonding techniquecomposite restoration carried out using self etch bonding agent and no rebonding technique is done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- class 1 carious lesion in premolar and molars clinically diagnosed as moderate occlusal caries extending up to middle third of dentin no caries on any other surface of tooth patients with sign and symptom of reversible pulpitis like sharp pain, sensitivity to hot and cold and sweet stimuli lasting foe few seconds
Key exclusion criteria (1 listed)
- history of generalized sensitivity cavities extending up to pulpal third of dentin cavities need to be restored with direct or indirect pulp capping poor oral hygiene or periodontal disease bruxism and other wear facets chronic anti inflammatory, analgesics or psychotropic drugs
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 |
|---|---|---|
| treatment group 1: total etch bonding agent used with rebonding techniqueclass 1 composite restoration is done using total etch type bonding agent and rebonding technique applied | Procedure or surgery | control group 1: total etch bonding agent without rebonding |
| treatment group 2: self etch bonding agent used with rebonding techniqueclass 1 composite restoration is done using self etch type bonding agent and rebonding technique applied | Procedure or surgery | Control group 2: self etch bonding agent without rebonding |
Primary outcome
Post-operative hypersensitivity
Time frame: from treatment to 24 hours and 1 week
Numeric pain intensity scale 0= no sensitivity 1-3= mild sensitivity 4-6= moderate sensitivity 10=worst possible sensitivity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Results publication: PubMed 28955539Tekce N, Demirci M, Gokturk SA, Tuncer S, Ozel E, Pala K, Baydemir C. The effect of bonding and surface sealant application on postoperative sensitivity from posterior composites. J Istanb Univ Fac Dent. 2015 Oct 21;49(3):1-10. doi: 10.17096/jiufd.33921. eCollection 2015.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment group 1: total etch bonding agent used with rebonding technique and treatment group 2: self etch bonding agent used with rebonding technique in people with Post-Operative Hypersensitivity, run by Foundation University Islamabad 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 1 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: enrolling by invitation, as of the sponsor's last update on 27 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: from treatment to 24 hours and 1 week). 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 NCT07041424, 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 27 Jun 2025.