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CompletedNCT07862270Updated Oct 7, 2026

Comparison of Post-Operative Sensitivity of 5th Genaration Bonding Agent With 8th Generation Bonding Agent in Class1 Composite Restoration

An interventional study of 5th generation bonding agent and 8th generation bonding agent in Dentin Sensitivity, sponsored by Rehman Medical Institute - RMI. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Rehman Medical Institute - RMI · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2026, registered Oct 2026).
Updated Oct 7, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The goal of this randomized clinical trial is to compare post-operative sensitivity after Class I composite restorations using 5th-generation and 8th-generation bonding agents in adults aged 18 to 50 years. The main question is whether the level of sensitivity differs between the two bonding agents. Participants will be randomly assigned to receive either a 5th-generation or an 8th-generation bonding agent during their composite restoration. Sensitivity will be measured using a 0-10 Visual Analogue Scale immediately after treatment, at 24 hours, and at 7 days after treatment.

Read the detailed description

This randomized clinical trial will compare post-operative sensitivity following Class I composite restorations performed using a 5th-generation bonding agent and an 8th-generation bonding agent. The study will include adult patients aged 18 to 50 years who require a Class I composite restoration and meet the study eligibility criteria.

Eligible participants will be randomly allocated into two groups. Group A will receive a 5th-generation bonding agent using a total-etch technique. Group B will receive an 8th-generation bonding agent using a self-etch technique. Standardized Class I cavity preparations will be restored using composite resin under rubber dam isolation.

Before treatment, baseline sensitivity will be assessed using standardized cold and air stimuli. Following restoration, post-operative sensitivity will be assessed using a 0-10 Visual Analogue Scale, where 0 represents no pain and 10 represents the worst possible pain. Sensitivity scores will be recorded immediately after treatment, at 24 hours, and at 7 days after treatment.

The primary purpose of the study is to compare post-operative sensitivity between the two bonding-agent groups at the specified follow-up time points. The study findings will help determine whether the type of bonding agent used with Class I composite restorations is associated with differences in post-operative sensitivity.

02

Conditions studied

  • Dentin Sensitivity

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03

In context

Dentin Sensitivity

289 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 280 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Rehman Medical Institute - RMI is the lead sponsor of 21 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 to 50 years.
  • Patients requiring Class 1 composite restorations.
  • Patients of both genders were included.
  • Patients with good oral hygiene and no periodontal disease.
  • Patients with cavity depth 3mm measured on radiograph.

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of hypersensitivity or allergy to dental materials.
  • Patients with systemic conditions that affect oral health.
  • Pregnant or lactating women.
  • Patients who have used analgesics or anti-inflammatory drugs within the past 24 hours.
  • Patients who are unable or unwilling to comply with scheduled follow up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    5th Generation bonding agent for composite restoration

    Device: 5th generation bonding agent

  • Experimental
    8th Generation bonding agent for composite restorstion

    Device: 8th generation bonding agent

Interventions

  • Device5th generation bonding agent

    A 5th-generation total-etch adhesive system will be used for bonding composite resin in Class I restorations. The enamel and dentin will be etched with phosphoric acid according to the manufacturer's instructions, followed by application of the bonding agent. The composite restoration will then be placed according to the standardized clinical protocol. Post-operative sensitivity will be assessed using a visual analogue scale (VAS) at the specified follow-up periods.

  • Device8th generation bonding agent

    An 8th-generation self-etch adhesive system will be used for bonding composite resin in Class I restorations. The adhesive will be applied according to the manufacturer's instructions, followed by placement of the composite restoration using the standardized clinical protocol. Post-operative sensitivity will be assessed using a visual analogue scale (VAS) at the specified follow-up periods.

06

What researchers measure

Primary outcomes

  1. Post-operative sensitivity assessed using Visual Analogue Scale (VAS)

    Post-operative sensitivity will be measured using a 0-10 Visual Analogue Scale (VAS) following standardized cold stimulation. The VAS score will be recorded immediately after treatment, at 24 hours, and at 7 days.

    Time frame: Immediately after treatment, 24 hours, and 7 days after treatment

07

Study locations

1 site
  • Rehman College of Dentistry ,Peshawar, Pakistan
    Peshawar, KPK, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers. Study data will be kept confidential and used only for the purposes described in the study protocol.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2026 to primary completion in Aug 2026, 5 months.

Of 109 non-industry interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 5 months is below that.

Counting every sponsor, half of 142 studies reached it within 6 months; a quarter within 3 and three quarters within 11.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2026
First posted
Oct 7, 2026
StartActual
Mar 1, 2026
Primary completionActual
Aug 30, 2026
CompletionActual
Aug 30, 2026
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07862270
Lead sponsor
Rehman Medical Institute - RMI
Responsible party
Momina Illiyeen (Post Graduate Trainee, Rehman Medical Institute - RMI) — Principal investigator
First posted
Oct 7, 2026
Start date
Mar 1, 2026
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026
Last update
Oct 7, 2026

Study contacts

MOMINA ILLIYEEN, BDS
principal investigator · Rehman College of Dentistry Peshawar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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