Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

NCT ID: NCT02921165

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-06-30

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.

Conditions

Periodontitis; Dental Caries; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group 1

Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)

Group Type: ACTIVE_COMPARATOR

analgesic mouth rinses (dissolved Aspirin)

Intervention Type: DRUG

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.

Group 2

Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)

Group Type: EXPERIMENTAL

analgesic mouth rinses (dissolved Aspirin)

Intervention Type: DRUG

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.

Group 3

Non Hypertensive Intervention: On normal saline rinses.

Group Type: EXPERIMENTAL

Normal saline rinses.

Intervention Type: DRUG

Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.

Interventions

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.

Intervention Type: DRUG

Normal saline rinses.

Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.

Intervention Type: DRUG

Other Intervention Names

water dissolved aspirin rinse; warm saline rinses; salt water rinses

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Rabia Ali

Dr. Rabia Ali

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia Ali, BDS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Farhan Raza Kahn, FCPS

Role: STUDY_DIRECTOR

Aga Khan University

Other Identifiers

AgaKhanUniversity

Identifier Type: -

Identifier Source: org_study_id