Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

Phase 4

Completed

• Conditions: Periodontitis; Dental Caries; Hypertension
• Interventions: Drug: analgesic mouth rinses (dissolved Aspirin); Drug: Normal saline rinses.

• Registration Number: NCT02921165
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Study First Posted: 2016-10-03
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	analgesic mouth rinses (dissolved Aspirin)	Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Group 2	analgesic mouth rinses (dissolved Aspirin)	Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Group 3	Normal saline rinses.	Non Hypertensive Intervention: On normal saline rinses.

Primary Outcome Measures

Name	Time	Method
Number of participants with unhealed extraction socket	Number of participants with unhealed extraction socket at 7th day