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Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

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ClinicalTrials.gov Identifier: NCT02921165
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Rabia Ali, Aga Khan University

Brief Summary:
The aim of this study is to determine the beneficial effect of mouth rinses, both topical analgesic and saline regimens as an adjuvant therapy in the presence of standard prescription of post-operative pain killers on the progress of socket healing following routine dental extraction.

Condition or disease Intervention/treatment Phase
Periodontitis Dental Caries Hypertension Drug: analgesic mouth rinses (dissolved Aspirin) Drug: Normal saline rinses. Phase 4

Detailed Description:

Hypertension is a highly prevalent cardiovascular disease, which affects over 1 billion people worldwide. It varies with age, race, education and so forth.1 The National Health Survey of Pakistan estimated that hypertension affects 18% of adults and 33% of adults are above 45 years old.2It is a common disease encountered in dental setting. Its wide spreading, terrible consequences, and life-long treatment require an attentive approach by dentists. Knowledge of hypertension is important for dentists especially for risk assessment for dental treatment. This may lead to improved monitoring and treatment.

Dental treatment in hypertensive patients necessitates special attention, because any stressful procedure may increase blood pressure and trigger acute complications such as cardiac arrest or stroke. Extractions are usually done for teeth which are not salvageable. Dentists routinely advice use of warm saline rinses to help in healing of post extraction socket. But for hypertensive patients this recommendation is potentially harmful There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Moreover, advantage of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-hypertensive Subjects
Study Start Date : May 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Group 1
Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Drug: analgesic mouth rinses (dissolved Aspirin)
Group 1 and Group 2 patients will be prescribed analgesic mouth rinses (dissolved Aspirin) twice daily along with the standard prescription of analgesics and antibiotics.
Other Name: water dissolved aspirin rinse

Experimental: Group 2
Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Drug: analgesic mouth rinses (dissolved Aspirin)
Group 1 and Group 2 patients will be prescribed analgesic mouth rinses (dissolved Aspirin) twice daily along with the standard prescription of analgesics and antibiotics.
Other Name: water dissolved aspirin rinse

Experimental: Group 3
Non Hypertensive Intervention: On normal saline rinses.
Drug: Normal saline rinses.
Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.
Other Names:
  • warm saline rinses
  • salt water rinses




Primary Outcome Measures :
  1. Number of participants with unhealed extraction socket [ Time Frame: Number of participants with unhealed extraction socket at 7th day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects requiring simple tooth extraction (elevator or forceps) which were either known cases of controlled hypertension under medical treatment or confirmed non hypertensives.

Exclusion Criteria:

  • Subjects requiring surgical tooth extraction involving bone removal and suturing, uncontrolled systemic disorders (diabetes mellitus, hypertension, blood coagulopathies, metabolic bone disorders), on platelet aggregation therapy or warfarin (anticoagulants) or bisphosphonate therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921165


Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Rabia Ali, BDS Aga Khan University Hospital
Study Director: Farhan Raza Kahn, FCPS Aga Khan University Hospital

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Responsible Party: Rabia Ali, Dr. Rabia Ali, Aga Khan University
ClinicalTrials.gov Identifier: NCT02921165     History of Changes
Other Study ID Numbers: AgaKhanUniversity
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rabia Ali, Aga Khan University:
tooth extraction
tooth socket healing
hypertension
rinses
Additional relevant MeSH terms:
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Periodontitis
Dental Caries
Hypertension
Vascular Diseases
Cardiovascular Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Aspirin
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics