Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing
Primary Purpose
Periodontitis, Dental Caries, Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
analgesic mouth rinses (dissolved Aspirin)
Normal saline rinses.
Sponsored by
About this trial
This is an interventional supportive care trial for Periodontitis focused on measuring tooth extraction, tooth socket healing, hypertension, 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Non Hypertensive Intervention: On normal saline rinses.
Outcomes
Primary Outcome Measures
Number of participants with unhealed extraction socket
Secondary Outcome Measures
Full Information
NCT ID
NCT02921165
First Posted
September 23, 2016
Last Updated
September 29, 2016
Sponsor
Aga Khan University
1. Study Identification
Unique Protocol Identification Number
NCT02921165
Brief Title
Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing
Official Title
Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-hypertensive Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Dental Caries, Hypertension
Keywords
tooth extraction, tooth socket healing, hypertension, rinses
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin)
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Non Hypertensive Intervention: On normal saline rinses.
Intervention Type
Drug
Intervention Name(s)
analgesic mouth rinses (dissolved Aspirin)
Other Intervention Name(s)
water dissolved aspirin rinse
Intervention Description
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
Intervention Name(s)
Normal saline rinses.
Other Intervention Name(s)
warm saline rinses, salt water rinses
Intervention Description
Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.
Primary Outcome Measure Information:
Title
Number of participants with unhealed extraction socket
Time Frame
Number of participants with unhealed extraction socket at 7th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ali, BDS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farhan Raza Kahn, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing
We'll reach out to this number within 24 hrs