A study to see if combining enzyme supplement with diclofenac tablet works better than diclofenac alone for pain reduction and healing after minor oral surgery.

EFFICACY OF ORAL ENZYME COMBINATION WITH DICLOFENAC SODIUM VERSUS DICLOFENAC ALONE FOR ANALGESIC, ANTI-INFLAMMATORY AND WOUND HEALING OUTCOMES AFTER FRENECTOMY: A RANDOMIZED CONTROLLED TRIAL - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098306

Enrollment

Registered

2025-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: Oral Enzyme combination with Diclofenac(Rutoheal-D): Oral enzyme combinations (OECs) are a potentially beneficial approach for reducing post-operative pain and inflammation. In orthogna

it is used to treat rheumatoid and osteoarthritis, bursitis, ankylosing spondylitis, toothache, post-traumatic and postoperative inflammatory conditions, and it is a preferential COX-2 inhibitor. It i

Eligibility

Inclusion criteria

Inclusion criteria: Systemically healthy patient Patient age ranging 18-35 years Papillary and papillary penetrating frenal attachment Patient who have agreed to participate in the study

Exclusion criteria

Exclusion criteria: The patients who are undergoing treatment with analgesics or corticosteroids during the trial period Pregnancy and lactating mothers Smokers and alcoholic Patients with cardiovascular disease and stroke Patients with gastrointestinal bleeding or ulcers Patients with liver disease Patients with kidney disease Patients with known hypersensitivity reactions to oral enzyme combinations and diclofenac

Design outcomes

Primary

Measure	Time frame
To evaluate the analgesic, anti-inflammatory and wound healing efficacy of oral enzyme combination with diclofenac sodium versus diclofenac sodium alone following frenectomyTimepoint: 1 day, 3 days, 7 days	—

Secondary

Measure	Time frame
To compare and evaluate the efficacy of analgesic, anti-inflammatory and wound healing efficacy of oral enzyme combination with diclofenac sodium and diclofenac sodium alone following frenectomyTimepoint: 1 day, 3 days, 7 days	—

Countries

India

Contacts

Public ContactDr Prakash Pai G

KVG Dental College and Hospital

prakashpaipai2014@gmail.com9845156405

Outcome results

None listed

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