Crown Lengthening Procedure With Ostectomy Clinical Trial
Official title:
Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure: A Placebo Control Trial
| Verified date | May 2018 |
| Source | Tatyasaheb Kore Dental College |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | February 8, 2017 |
| Est. primary completion date | January 31, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 17 Years to 55 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| India | Dental | Kolhapur | Maharashtra |
| Lead Sponsor | Collaborator |
|---|---|
| Tatyasaheb Kore Dental College |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Analog Scale | Pain Assessment is done by visual analog scale which consists of 10 centimeter line. anchored by two extremes starting from 1 ending to 10, of which 1 being the lowest and 10 being highest score. | 3 days |