Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-hypertensive Subjects

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Periodontitis; Dental Caries
• Intervention / Treatment: Drug: analgesic mouth rinses (dissolved Aspirin); Drug: Normal saline rinses.

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with unhealed extraction socket	Number of participants with unhealed extraction socket at 7th day

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Rabia Ali, BDS, Aga Khan University; Study Director: Farhan Raza Kahn, FCPS, Aga Khan University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): October 3, 2016

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: hypertension; tooth extraction; tooth socket healing; rinses
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Hypertension; Periodontitis; Dental Caries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Analgesics
• Other Study ID Numbers: AgaKhanUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO