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A clinical trial to analyze the effects of the drugs Polidocanol and Sodium tetradecyl sulfate individually and in combination with the drug dexamethasone in the treatment of oral mucocele and pyogenic granuloma.

Evaluation of efficacy of Polidocanol and Sodium tetradecyl sulfate (sts) individually and in combination with dexamethasone in the management of oral mucocele and pyogenic granuloma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042809
Enrollment
96
Registered
2022-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Health Condition 1: K137- Other and unspecified lesions of oral mucosa

Interventions

Intervention1: Polidocanol: Intralesional injection of Polidocanol 3% will be given to patients having oral pyogenic granuloma until the solution leaks out of the lesion. The amount of drug that will

Sponsors

Dr Trupti Vijay Gaikwad
Lead Sponsor
Dr D Y Patil Dental College and Hospital Pune
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged above 15 years. 2. Patients who were ready to give informed consent. 3. Patients clinically diagnosed with Oral Mucocele or pyogenic granuloma.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding patients. 2. Patients with h/o chest infections. 3. Cases with acute Deep vein thrombosis (DVT). 4. Patient with underlying systemic illness. 5. Patients on anticoagulants, disulfiram, and tamoxifen

Design outcomes

Primary

MeasureTime frame
1) size of the lesion: Size of the lesion will be measured 2) Recurrence of the lesion will be checked. 3) Assessment of pain after intralesional injection.Timepoint: 1) size of the lesion: Size of the lesion will be measured with the help of vernier calliper before therapy, 1 week after therapy, 1 week after 1st injection, 1 week after 2nd injection, 1 week after 3rd injection and 1 week after 4th injection. Patient will be followed up every week. 2) Recurrence of the lesion will be checked 1 month and 3 months after complete regression of the lesion.

Secondary

MeasureTime frame
1) Success rate: To establish the success rate in terms of partial or complete resolution of the lesion.Timepoint: 1 week after therapy, 1 week after 1st injection, 1 week after 2nd injection, 1 week after 3rd injection and 1 week after 4th injection.

Countries

India

Contacts

Public ContactDr Trupti Vijay Gaikwad

Dr. D. Y. Patil Dental College and Hospital, Pune

mainianuj1976@gmail.com7973358337

Outcome results

None listed

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