ClinicalTrials.gg
CompletedNCT07821359Updated Oct 22, 2026

Comparison of Postoperative Pain After Root Canal Irrigation in Symptomatic Irreversible Pulpitis

An interventional study of Dexamethasone and Sodium Chloride 0.9% in Symptomatic Irreversible Pulpitis, sponsored by CMH Lahore Medical College and Institute of Dentistry. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by CMH Lahore Medical College and Institute of Dentistry · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2026, registered Sep 2026).
Updated Oct 22, 2026Now CompletedPrimary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This randomized controlled trial will compare postoperative pain following root canal treatment in patients with symptomatic irreversible pulpitis. The study will evaluate whether using dexamethasone as the final intracanal rinse provides better pain control than normal saline.

Patients requiring two-visit root canal treatment for symptomatic irreversible pulpitis will be randomly assigned to receive either dexamethasone or normal saline as the final rinse during root canal treatment. All participants will otherwise receive the standard root canal treatment protocol.

Postoperative pain will be assessed using a Visual Analog Scale (VAS) at the specified follow-up time points after treatment. Pain scores between the two groups will be compared to determine whether the addition of dexamethasone as a final intracanal rinse reduces postoperative pain.

Read the detailed description

Postoperative pain is a common concern following root canal treatment and may persist because of inflammation associated with the treatment of symptomatic irreversible pulpitis. Although corticosteroids such as dexamethasone have established anti-inflammatory effects, limited information is available regarding their use specifically as a final intracanal rinse during root canal treatment.

This study will evaluate the effect of dexamethasone used as a final intracanal rinse on postoperative pain in patients with symptomatic irreversible pulpitis undergoing two-visit root canal treatment. Participants will be randomly allocated to one of two parallel groups. The dexamethasone group will receive dexamethasone as the final intracanal rinse, whereas the control group will receive an equal volume of normal saline.

Both groups will undergo the same conventional endodontic treatment protocol, with sodium hypochlorite used during canal irrigation. In the intervention group, 1 mL of dexamethasone solution (4 mg/4 mL) will be used as the final rinse, while the control group will receive 1 mL of normal saline as the final rinse. The root canal treatment will be completed at the second appointment one week after the first visit.

Postoperative pain will be assessed using a 10-point Visual Analog Scale, with higher scores indicating greater pain intensity. The pain scores of participants receiving dexamethasone will be compared with those receiving normal saline to determine whether dexamethasone as a final intracanal rinse is associated with reduced postoperative pain.

The study will be conducted as a two-arm, parallel randomized controlled trial at the Department of Operative Dentistry, Institute of Dentistry, CMH Lahore Medical College. A total of 72 participants will be enrolled, with 36 participants allocated to each study group.

02

Conditions studied

  • Symptomatic Irreversible Pulpitis

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Keywords

  • Symptomatic irreversible pulpitis
  • Postoperative endodontic pain
  • Root canal treatment
  • Dexamethasone
  • Intracanal irrigation
03

In context

Pulpitis

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's enrollment of 72 is above the median of 64 across 288 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

CMH Lahore Medical College and Institute of Dentistry is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 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

  1. Adults aged 18-65 years.
  2. Patients diagnosed with symptomatic irreversible pulpitis in a maxillary or mandibular premolar or molar.
  3. Positive response to cold/thermal pulp testing and electric pulp testing.
  4. Clinical features consistent with symptomatic irreversible pulpitis, including spontaneous pain and/or pain elicited by thermal stimuli, with clinically evident deep carious involvement or pulpal exposure.
  5. Patients indicated for two-visit root canal treatment.
  6. Ability to understand and complete the Visual Analogue Scale (VAS) for pain assessment.
  7. Absence of active periodontal disease.

Exclusion criteria

Exclusion Criteria:

  1. Use of analgesics, antibiotics, or anti-inflammatory medications within 24 hours before treatment.
  2. History of chronic pain.
  3. Evidence of periapical involvement or pathology, including periapical abscess, sinus tract, or periapical cyst.
  4. Pulp necrosis.
  5. Internal or external root resorption.
  6. Unfavourable tooth position, ankylosis, trismus, or significant malposition associated with traumatic occlusion.
  7. status.
  8. Known allergy or to local anaesthetic or dexamethasone.
  9. Previous endodontic treatment of the study tooth.
  10. Non-restorable teeth or unfavourable crown-to-root ratio.
  11. Inability to understand or reliably use the VAS.
  12. Inability or unwillingness to attend follow-up assessments.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Dexamethasone Final Rinse

    Participants will receive conventional root canal irrigation with saline and 3% sodium hypochlorite, followed by 1 mL of dexamethasone solution (4 mg/4 mL; 1 mg/mL) as the final intracanal rinse before obturation. Root canal treatment will be performed over two visits according to the standardized study protocol.

    Drug: Dexamethasone

  • Active comparator
    Normal Saline Final Rinse

    Participants will receive conventional root canal irrigation with saline and 3% sodium hypochlorite, followed by 1 mL of normal saline as the final intracanal rinse before obturation. Root canal treatment will be performed over two visits according to the standardized study protocol.

    Drug: Sodium Chloride 0.9%

Interventions

  • Dexamethasone solution (4 mg/4 mL; 1 mg/mL) will be used as an adjunctive final intracanal rinse during two-visit root canal treatment in patients with symptomatic irreversible pulpitis. Following conventional irrigation with saline and 3% sodium hypochlorite, 1 mL of dexamethasone solution will be delivered into the root canal(s) as the final rinse before obturation. The intervention is intended to reduce postoperative inflammation and pain.

  • DrugSodium Chloride 0.9%

    Sodium chloride 0.9% solution will be used as the comparator final intracanal rinse during two-visit root canal treatment in patients with symptomatic irreversible pulpitis. Following conventional irrigation with saline and 3% sodium hypochlorite, 1 mL of sodium chloride 0.9% solution will be delivered into the root canal(s) as the final rinse before obturation.

06

What researchers measure

Primary outcomes

  1. Postoperative pain intensity measured using the Visual Analogue Scale (VAS)

    Postoperative pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Pain scores will be recorded at 24 hours, 48 hours, and 7 days after root canal treatment and compared between the dexamethasone and normal saline groups.

    Time frame: 24 hours, 48 hours, and 7 days after root canal treatment

07

Study locations

1 site
  • CMH Lahore
    Lahore, 54000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 22, 2026
Primary completion
Sep 12, 2026→Sep 25, 2026 (actual)
Sep 29, 2026
Show all 2 updates
  1. Oct 22, 2026
    Active, not recruiting→Completed
    + 2 other changes: verification date and date precision
  2. Sep 29, 2026
    Primary completion Sep 12, 2026→Sep 25, 2026 (now actual)

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
NCT07821359
Lead sponsor
CMH Lahore Medical College and Institute of Dentistry
Responsible party
Sponsor
First posted
Sep 15, 2026
Start date
Feb 28, 2026
Primary completion
Sep 25, 2026
Completion
Sep 30, 2026
Last update
Oct 22, 2026

Study contacts

Sobia M Tirmizi, BDS, FCPS
study chair · CMH Lahore Medical College and Institute of Dentistry

Oversight

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

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Studies of the drug tested here: Dexamethasone

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