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Preemptive Analgesia for Pain Reduction After Orthodontic Extractions: A Split Mouth Trial

Evaluating the Efficacy of Preemptive Analgesia in Reducing Postoperative Pain After Orthodontic Extractions: A Split Mouth Triple-Blind Randomized PlaceboControlled Trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088765
Enrollment
47
Registered
2025-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: K009- Disorder of tooth development, unspecified

Interventions

Intervention1: The intervention in this study is a single oral dose of ibuprofen 400 mg administered one hour prior to the orthodontic extraction procedure. Ibuprofen is a non-steroidal anti-inflammat

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy subjects aged 14 - 35 years (Both genders) ASA I classification, Require bilateral maxillary and mandibular premolar extractions for orthodontic treatment. Surgical sites should be comparable in terms of difficulty. Both premolars should be free of active infection, periodontal disease, or extensive decay, with adequate bone support and no signs of impaction or surgical complications at the extraction site. Participants (or guardians, if minors) must provide written informed consent. Patients without deleterious habits such as pan/gutka chewing, smoking, and alcohol use.

Exclusion criteria

Exclusion criteria: Recent (within 7 days) or concurrent use of anti-inflammatory drugs, corticosteroids, or other medications that may interfere with pain assessment. Allergy or hypersensitivity to the analgesic agents being studied, Active gastrointestinal bleeding or peptic ulcer. Significant differences in surgical difficulty between sides, the presence of impacted or supernumerary teeth in the extraction area. Patients with systemic illnesses such as diabetes, bleeding disorders. Women who are pregnant, planning to conceive. Patients with intellectual disability affecting pain perception or adherence to protocols, as well as those with extreme dental anxiety interfering with pain reporting.

Design outcomes

Primary

MeasureTime frame
To evaluate effectiveness of preemptive analgesia in reducing postoperative pain after orthodontic extractions using a 10-point visual analog scale.Timepoint: 1, 6, 12, 24, 48 hours post extraction

Secondary

MeasureTime frame
data will be collected for both groups regarding the use of rescue medication, including: (1) The time interval between the completion of the surgical procedure and the patient s first analgesic intake. (2) The total number of rescue analgesic doses consumed. Adverse events will also be recorded to assess the overall effectiveness and safety of the intervention.Timepoint: 1, 6, 12, 24, 48, and 72 hours after surgery

Countries

India

Contacts

Public ContactFrijo Xavier

All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD

dranurag.aiims@gmail.com8884070768

Outcome results

None listed

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