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OpenTrials
Completed

NCT Number: NCT02921165

Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

analgesic mouth rinses (dissolved Aspirin)

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.

Other names: water dissolved aspirin rinse

Normal saline rinses.

Drug

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 outcomes

  1. Number of participants with unhealed extraction socket

    Time frame: Number of participants with unhealed extraction socket at 7th day

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2016
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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