Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain

NCT ID: NCT03006107

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-01-31

Brief Summary

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to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

Detailed Description

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The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

Conditions

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Pulpitis - Irreversible

Keywords

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Irreversible pulpitis Post endodontic pain Symptomatic pulpitis pain Single visit RCT pain Root canal treatment flare up Single dose piroxicam Intraligamentary piroxicam Intraligamentary mepecaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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intraligamentary injection of piroxicam

intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .

The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone

Group Type EXPERIMENTAL

intraligamentary injection piroxicam

Intervention Type PROCEDURE

intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .

The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone

Intraligamentary mepevacaine

mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.

Group Type ACTIVE_COMPARATOR

Intraligamentary mepevacaine

Intervention Type PROCEDURE

mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.

Interventions

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intraligamentary injection piroxicam

intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .

The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone

Intervention Type PROCEDURE

Intraligamentary mepevacaine

mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* • Medically free patients

* Patient's age between 25-50 years.
* Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis.
* Positive patient's acceptance for participation in the study.
* Sex include both male and female.
* Patients who can understand Numerical Rating Scale (NRS)
* Patients able to sign informed consent.

Exclusion Criteria

* • Pregnancy or lactation in female patients

* Medically compromised patients.
* Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral.
* Patient with fracture or mobile or mutilated teeth.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Gamal Ahmed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angie g Ghoneim, Professor

Role: STUDY_CHAIR

Department of endodontics - Faculty of Oral and Dental medicine - CU

marwa ga ahmed, student

Role: PRINCIPAL_INVESTIGATOR

Department of endodontics - Faculty of Oral and Dental medicine - CU

Central Contacts

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marwa ga ahmed, student

Role: CONTACT

Phone: 01286171420

Email: [email protected]

Sherif A El khodary, Lecturer

Role: CONTACT

Phone: 01006609198

References

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Penniston SG, Hargreaves KM. Evaluation of periapical injection of Ketorolac for management of endodontic pain. J Endod. 1996 Feb;22(2):55-9. doi: 10.1016/S0099-2399(96)80272-X.

Reference Type BACKGROUND
PMID: 8935018 (View on PubMed)

Pharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007

Reference Type BACKGROUND

3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105

Reference Type BACKGROUND

Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.

Reference Type BACKGROUND
PMID: 22432824 (View on PubMed)

Torabinejad M, Bakland LK. Prostaglandins: their possible role in the pathogenesis of pulpal and periapical diseases, part 2. J Endod. 1980 Oct;6(10):769-76. doi: 10.1016/S0099-2399(80)80107-5. No abstract available.

Reference Type BACKGROUND
PMID: 7005368 (View on PubMed)

Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.

Reference Type BACKGROUND
PMID: 3863874 (View on PubMed)

McNicholas S, Torabinejad M, Blankenship J, Bakland L. The concentration of prostaglandin E2 in human periradicular lesions. J Endod. 1991 Mar;17(3):97-100. doi: 10.1016/S0099-2399(06)81737-1.

Reference Type BACKGROUND
PMID: 1940730 (View on PubMed)

Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.

Reference Type BACKGROUND
PMID: 21902704 (View on PubMed)

Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.

Reference Type BACKGROUND
PMID: 12148679 (View on PubMed)

Maccagno A, Di Giorgio EE, Caston OL, Sagasta CL. Double-blind controlled clinical trial of oral S-adenosylmethionine versus piroxicam in knee osteoarthritis. Am J Med. 1987 Nov 20;83(5A):72-7. doi: 10.1016/0002-9343(87)90855-2.

Reference Type BACKGROUND
PMID: 3318443 (View on PubMed)

Other Identifiers

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piroxicam _ Mepecaine

Identifier Type: -

Identifier Source: org_study_id