Crown Lengthening Procedure With OstectomyNCT03520595
Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure
A study testing Arnica 200 drug 3 pills,3 times daily for 3 days and Diclofenac Sodium 50mg twice daily in people with Crown Lengthening Procedure With Ostectomy, run by Tatyasaheb Kore Dental College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Crown Lengthening Procedure With Ostectomy
- What is being tested?
- Arnica 200 drug 3 pills,3 times daily for 3 days and Diclofenac Sodium 50mg twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2016to 8 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Systemically healthy patients.
- Patients with inadequate crown height for replacement for prosthesis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure: A Placebo Control Trial
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.
Read more
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.
- Being tested
- Arnica 200 drug 3 pills,3 times daily for 3 days, Diclofenac Sodium 50mg twice daily, Placebo pills and distilled water 3 pills,3 times daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arnica 200 drug 3 pills,3 times daily for 3 daysDrug
Also called CLP with ostectomy
CLP with ostectomy done in patients whose biologic width and crown height is insufficient
Diclofenac Sodium 50mg twice dailyDrug
Also called CLP with ostectomy
CLP with ostectomy done in patients whose biologic width and crown height is insufficient
Placebo pills and distilled water 3 pills,3 times dailyDrug
Also called CLP with ostectomy
CLP with ostectomy done in patients whose biologic width and crown height is insufficient
| Study group | Role | What they receive |
|---|---|---|
| Arnica Group | Active comparator | Study group 1 CLP with ostectomy Arnica 200 drug 3 pills,3 times daily for 3 days Receives: Drug: Arnica 200 drug 3 pills,3 times daily for 3 days |
| Diclofenac Sodium group | Active comparator | Study group 2 CLP with ostectomy Diclofenac Sodium 50mg twice daily after meals with plain water Receives: Drug: Diclofenac Sodium 50mg twice daily |
| Placebo Group | Placebo comparator | Study group 3 CLP with ostectomy Placebo pills and distilled water 3 pills,3 times daily Receives: Drug: Placebo pills and distilled water 3 pills,3 times daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Dec 2016
- Primary completion31 Jan 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crown Lengthening Procedure With OstectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Nibha Suneel Kulkarni, Tatyasaheb Kore Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520595
- Sponsor's protocol ID
- Tatyasaheb kore dental c
- Status last verified
- May 2018
- First submitted
- 31 Jan 2017
- Last updated
- 15 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure: A Placebo Control Trial
- ClinicalTrials.gov ID
- NCT03520595
- Acronym / sponsor ID
- Tatyasaheb kore dental c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arnica Group | Active comparator | Drug: Arnica 200 drug 3 pills,3 times daily for 3 daysStudy group 1 CLP with ostectomy Arnica 200 drug 3 pills,3 times daily for 3 days |
| Diclofenac Sodium group | Active comparator | Drug: Diclofenac Sodium 50mg twice dailyStudy group 2 CLP with ostectomy Diclofenac Sodium 50mg twice daily after meals with plain water |
| Placebo Group | Placebo comparator | Drug: Placebo pills and distilled water 3 pills,3 times dailyStudy group 3 CLP with ostectomy Placebo pills and distilled water 3 pills,3 times daily |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Systemically healthy patients.
- Patients with inadequate crown height for replacement for prosthesis.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arnica 200 drug 3 pills,3 times daily for 3 daysAlso: CLP with ostectomyCLP with ostectomy done in patients whose biologic width and crown height is insufficient | Drug | Arnica Group |
| Diclofenac Sodium 50mg twice dailyAlso: CLP with ostectomyCLP with ostectomy done in patients whose biologic width and crown height is insufficient | Drug | Diclofenac Sodium group |
| Placebo pills and distilled water 3 pills,3 times dailyAlso: CLP with ostectomyCLP with ostectomy done in patients whose biologic width and crown height is insufficient | Drug | Placebo Group |
Primary outcome
Visual Analog Scale
Time frame: 3 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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Comparison of Er:YAG Assisted Laser Crown Lengthening Against Surgical Crown Lengthening
Crown Lengthening, Crown Lengthening Procedure With Ostectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arnica 200 drug 3 pills,3 times daily for 3 days and Diclofenac Sodium 50mg twice daily in people with Crown Lengthening Procedure With Ostectomy, run by Tatyasaheb Kore Dental College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.