Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure

NCT ID: NCT03520595

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2017-02-08

Brief Summary

Introduction:

Homeopathy is a deep healing, comprehensive and distinct system originally developed by Samuel Hahnemann about 200 years ago. Small doses of specially prepared ("potentized") remedies which set the body's systems back in order and stimulate a body's own energies toward a natural healing process. It is entirely distinct in both theory and in practice from other healing systems from ordinary or main-stream ("allopathic") medicine, but also from acupuncture, naturopathy, chiropractics, etc., although some homeopathy often finds its way into these other fields of practice.Homeopathy is based on the concept "similia similibus curentur" which means symptoms, caused by the original substance in healthy subjects, can be reversed by the homeopathic remedy in patients having similar symptoms.Homeopathy has the advantages such as it is inexpensive (the only expense is the homeopath's time and training - the remedies themselves cost practically nothing), non-toxic (although "side affects" which reflect the body's own healing processes may occur - such as fever, discharge, rash, etc.) and non-intrusive (the remedies are carried on tiny sugar granules which are dissolved in water or in the mouth, or swallowed).Arnica is one of the most popular medications in homeopathy medicine. This remedy can be extracted from several plant species belonging to the Aesteraceae family including Arnica montana, Arnica fulgens, Arnica cordifolia, Arnica chamissonis and Arnica sororia, and it is widely sold as tincture, ointment, cream, gel, and tablet. It has been used for the treatment of numerous pathological conditions, including pain, swelling and stiffness associated with trauma, contusions, sprains, myocarditis, angina pectoris, cardiac insufficiency, arteriosclerosis, postoperative clinical conditions, and for symptomatic relief in osteoarthritis.Conventional NSAIDs work by inhibiting cyclooxygenase (COX) and prostaglandin synthesis as well as by other less understood mechanisms. Onset of analgesia occurs rapidly with all NSAIDs, usually within one hour.Diclofenac is one of potent, standard and most unique NSAID for the therapy of postoperative pain. Diclofenac inhibits the lipoxygenase pathways, which reduces the formation of the leukotrienes (also pro-inflammatory autacoids) and also inhibit phospholipase A2. These actions explain the high potency of diclofenac.NSAIDs cause a variety of side effects including nausea, diarrhea, constipation, dizziness, headache, confusion, edema, rash, and pruritis. They can also cause more serious toxicities such as gastrointestinal (GI) ulceration/bleeding, hematologic disturbances, bronchospasm, angioedema, renal dysfunction, and hepatotoxicity. Many of these side effects are due to NSAID inhibiting prostaglandin synthesis other than at the desired site of action.Arnica being clinical efficient and high tolerable makes it a potential therapeutic alternative target to non-steroidal anti-inflammatory drugs.In this study investigator will compare and evaluate the efficacy of Arnica as a substitute for analgesics such as Diclofenac Sodium, through which side effects of NSAIDS can be avoided and get the same analgesia effect through Arnica without any of the undesirable effects for minor surgical procedures.

AIM:

To compare and evaluate the analgesic effect of Arnica Montana with Diclofenac sodium after crown lengthening procedure with ostectomy.

Objectives:

To assess the analgesic effect on crown lengthening procedure with ostectomy patients of Arnica Montana and Diclofenac Sodium.

Conditions

Crown Lengthening Procedure With Ostectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arnica Group

Study group 1 CLP with ostectomy Arnica 200 drug 3 pills,3 times daily for 3 days

Group Type: ACTIVE_COMPARATOR

Arnica 200 drug 3 pills,3 times daily for 3 days

Intervention Type: DRUG

CLP with ostectomy done in patients whose biologic width and crown height is insufficient

Diclofenac Sodium group

Study group 2 CLP with ostectomy Diclofenac Sodium 50mg twice daily after meals with plain water

Group Type: ACTIVE_COMPARATOR

Diclofenac Sodium 50mg twice daily

Intervention Type: DRUG

CLP with ostectomy done in patients whose biologic width and crown height is insufficient

Placebo Group

Study group 3 CLP with ostectomy Placebo pills and distilled water 3 pills,3 times daily

Group Type: PLACEBO_COMPARATOR

Placebo pills and distilled water 3 pills,3 times daily

Intervention Type: DRUG

CLP with ostectomy done in patients whose biologic width and crown height is insufficient

Interventions

Arnica 200 drug 3 pills,3 times daily for 3 days

CLP with ostectomy done in patients whose biologic width and crown height is insufficient

Intervention Type: DRUG

Diclofenac Sodium 50mg twice daily

CLP with ostectomy done in patients whose biologic width and crown height is insufficient

Intervention Type: DRUG

Placebo pills and distilled water 3 pills,3 times daily

CLP with ostectomy done in patients whose biologic width and crown height is insufficient

Intervention Type: DRUG

Other Intervention Names

CLP with ostectomy; CLP with ostectomy; CLP with ostectomy

Eligibility Criteria

Inclusion Criteria

• Systemically healthy patients.
• Patients with inadequate crown height for replacement for prosthesis.

Exclusion Criteria

• Tobacco intake in any form and alcohol.
• Pregnant & lactating women.
• Any known/reported allergy to given drugs.
• On Antibiotics medications.
• Patient with the history of acidity ,gastric disorders.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tatyasaheb Kore Dental College

OTHER

Sponsor Role: lead

Responsible Party

Dr.Nibha Suneel Kulkarni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dental

Kolhāpur, Maharashtra, India

Countries

India

Other Identifiers

Tatyasaheb kore dental c

Identifier Type: -

Identifier Source: org_study_id