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A Comparative Study of Inflammation in Gum Fluid After Using Two Dental Treatments for Severe Tooth Pain

Comparative assessment of Interleukin 8 levels in Gingival Crevicular Fluid with and without Photobiomodulation in teeth undergoing Mineral Trioxide Aggregate pulpotomy for Symptomatic Irreversible Pulpitis in a tertiary care centre in Nagpur: An Open-Label Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084812
Enrollment
66
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Mineral trioxide aggregate pulpotomy with photobiomodulation: second group will be intervened by mineral trioxide aggregate pulpotomy with photobiomodulation, outcome is assessed by cha

Sponsors

1) DHR PG thesis Grant, Department of Health Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient age 18 -60 years.Non-contributory medical history (ASA1.Deep caries extending to pulp chamber.Vital mature first and second mandibular molar with symptoms of irreversible pulpitis. Tooth with positive response to pulp sensibility testing.Tooth should be restorable.Tooth with probing pocket depth and mobility should be within normal limits.

Exclusion criteria

Exclusion criteria: Teeth with immature roots. Teeth with clinical signs of pulp necrosis such as swelling or presence of sinus tract. Teeth with prominent radiolucency in the furcation area, presence of internal or external root resorption, and any calcification. Teeth with no evidence of bleeding after communication with pulp chamber. Absence of antagonist tooth. Had taken analgesics in the past 3 days or antibiotics in the past one month. Tooth with periapical lesion visible on radiograph. Teeth in which hemostasis after pulpotomy will not be achieved within 10 min.

Design outcomes

Primary

MeasureTime frame
To assess the changes in the IL8 levels in gingival crevicular fluid (GCF) with and without photobiomodulation in MTA pulpotomy.Timepoint: To assess the changes in the IL8 levels in gingival crevicular fluid (GCF) with and without photobiomodulation in MTA pulpotomy before starting the procedure and after 7 days.

Secondary

MeasureTime frame
Secondary outcome criteria to be performed every 3,6,12 months Clinical criteria: 1. Postoperative pain assessment using VAS after 24, 48, 72 hours & 7 days. 2.No history of spontaneous pain or discomfort except for the first 2 days after treatment. 3.No tenderness to palpation or percussion & the tooth is functional. 4.Normal mobility & probing pocket depth. 5.Soft tissues around the tooth are normal with no swelling or sinus tract. Radiographic criteria: 1.No pathosis evident on the radiograph such as periapical widening, root resorption, furcation involvement, or new periapical pathosis. 2.PAI scoreTimepoint: pain assessment using VAS at baseline & after 24, 48, 72 hours & 7 days. clinical & radiographic assessment every 3,6,12 months

Countries

India

Contacts

Public ContactDr Anjali Balasaheb Gayke

All India Institute of Medical Sciences , Nagpur

drneelamch@gmail.com9323218572

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026