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Evaluating Pain Relief: A Study on Three Analgesics for Patients Undergoing Guided Implant SurgeryEvaluating Pain Relief: A Study on Three Analgesics for Patients Undergoing Guided Implant Surgery

Comparative Evaluation of three drugs in pain control, reduction of inflammation and swelling in patients undergoing flapless implant surgery- A Single Dose, Double Blinded, Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084278
Enrollment
100
Registered
2025-04-07
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: K068- Other specified disorders of gingiva and edentulous alveolar ridge

Interventions

Intervention1: Three drugs Ibuprofen (400 mg), Celecoxib (200 mg), and Aceclofenac (100 mg) used as a single drug therapy to treat postoperative pain.: This study compares the effectiveness of three d

Sponsors

Saveetha Dental College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The inclusion criteria for ideal implant surgery include good systemic health with controlled medical conditions, absence of active periodontal disease or oral infections, and adequate oral hygiene. Patients must have sufficient bone volume and density to support the implant, along with healthy keratinized gingiva and proper soft tissue volume. Functional factors like balanced occlusion and the absence of parafunctional habits should be considered. Candidates should be psychologically prepared, have realistic expectations, and be committed to post-operative care. Implants are typically placed in adults with completed craniofacial growth, with no upper age limit if overall health permits.

Exclusion criteria

Exclusion criteria: uncontrolled systemic diseases such as diabetes or cardiovascular conditions, active periodontal disease, or untreated oral infections. Patients with insufficient bone quantity or quality who are unwilling to undergo bone augmentation are not ideal candidates. Heavy smoking, substance abuse, or severe bruxism can compromise healing and implant stability. Poor oral hygiene, lack of commitment to post-operative care, and unrealistic expectations also pose risks. Psychological disorders, recent radiation therapy to the head and neck, and incomplete craniofacial development in growing patients are additional contraindications. Proper patient selection is essential to ensure successful implant outcomes.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of the single-drug regimen in managing postoperative pain by assessing the Summed Pain Intensity Difference (SPID) over the first 12 hours after T0 (SPID12). To calculate Total Pain Relief (TOTPAR) values over 4, 8, 12, and 24 hours after T0. To assess SPID at 4, 8, and 12 hours after T0. To determine the time to confirmed perceptible pain relief (PR) and time to meaningful PR. To record the use of rescue medication. To measure Pain Intensity Difference (PID) at various time points: 4, 8, 12, 24, 48, 72 hours after T0. To calculate the time to peak PR.Timepoint: To evaluate the efficacy of the single-drug regimen in managing postoperative pain by assessing the Summed Pain Intensity Difference (SPID) over the first 12 hours after T0 (SPID12). To calculate Total Pain Relief (TOTPAR) values over 4, 8, 12, and 24 hours after T0. To assess SPID at 4, 8, and 12 hours after T0. To determine the time to confirmed perceptible pain relief (PR) and time to meaningful PR. To record the use of rescue medication. To measure Pain Intensity Difference (PID) at various time points: 4, 8, 12, 24, 48, 72 hours after T0. To calculate the time to peak PR.

Secondary

MeasureTime frame
Adverse effects of the drugs provided. Long term status of the implantTimepoint: 0-6 months

Countries

India

Contacts

Public ContactVamshi Nizampuram

Saveetha Dental College

vamshi.nizampuram@gmail.com8975566054

Outcome results

None listed

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