Symptomatic Irreversible PulpitisNCT07821359
Comparison of Postoperative Pain After Root Canal Irrigation in Symptomatic Irreversible Pulpitis
A study testing Dexamethasone and Sodium Chloride 0.9% in people with Symptomatic Irreversible Pulpitis, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Dexamethasone and Sodium Chloride 0.9%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2026to 30 Sep 2026
- Phase
- Interventional
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Patients diagnosed with symptomatic irreversible pulpitis in a maxillary or mandibular premolar or molar.
- Positive response to cold/thermal pulp testing and electric pulp testing.
- 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.
- Patients indicated for two-visit root canal treatment.
- Ability to understand and complete the Visual Analogue Scale (VAS) for pain assessment.
- Absence of active periodontal disease.
Who cannot join
- Use of analgesics, antibiotics, or anti-inflammatory medications within 24 hours before treatment.
- History of chronic pain.
- Evidence of periapical involvement or pathology, including periapical abscess, sinus tract, or periapical cyst.
- Pulp necrosis.
- Internal or external root resorption.
- Unfavourable tooth position, ankylosis, trismus, or significant malposition associated with traumatic occlusion.
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- Immunocompromised status.
- Known allergy or contraindication to local anaesthetic or dexamethasone.
- Previous endodontic treatment of the study tooth.
- Non-restorable teeth or unfavourable crown-to-root ratio.
- Inability to understand or reliably use the VAS.
- Inability or unwillingness to attend follow-up assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Pain After Root Canal Irrigation, With and Without Dexamethasone, for Symptomatic Irreversible Pulpitis
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.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Dexamethasone, Sodium Chloride 0.9%
- Keywords
- Symptomatic irreversible pulpitis, Postoperative endodontic pain, Root canal treatment, Dexamethasone, Intracanal irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
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.
Sodium Chloride 0.9%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Final Rinse | Experimental | 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. Receives: Drug: Dexamethasone |
| Normal Saline Final Rinse | Active comparator | 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. Receives: Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours, 48 hours, and 7 days after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start28 Feb 2026
- Primary completion25 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies 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
- Model description
- Two-arm, parallel-group, randomized controlled trial comparing postoperative pain following a dexamethasone final intracanal rinse versus normal saline in patients with symptomatic irreversible pulpitis undergoing two-visit root canal treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sobia M Tirmizi, BDS, FCPS, Study chair, CMH Lahore Medical College and Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821359
- Sponsor's protocol ID
- DSG-2022-262-4271
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No