PeriodontitisPhase 4NCT02921165
Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing
A Phase 4 study testing analgesic mouth rinses (dissolved Aspirin) and Normal saline rinses. in people with Periodontitis and Dental Caries, run by Aga Khan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dental Caries, Hypertension
- What is being tested?
- analgesic mouth rinses (dissolved Aspirin) and Normal saline rinses.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects requiring simple tooth extraction (elevator or forceps) which were either known cases of controlled hypertension under medical treatment or confirmed non hypertensives.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- analgesic mouth rinses (dissolved Aspirin), Normal saline rinses.
- Keywords
- tooth extraction, tooth socket healing, hypertension, rinses
- Medical subject headings
- Periodontitis, Dental Caries, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analgesic mouth rinses (dissolved Aspirin)Drug
Also called water dissolved aspirin rinse
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.
Normal saline rinses.Drug
Also called warm saline rinses, salt water rinses
Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin) Receives: Drug: analgesic mouth rinses (dissolved Aspirin) |
| Group 2 | Experimental | Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin) Receives: Drug: analgesic mouth rinses (dissolved Aspirin) |
| Group 3 | Experimental | Non Hypertensive Intervention: On normal saline rinses. Receives: Drug: Normal saline rinses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with unhealed extraction socket
Measured: Number of participants with unhealed extraction socket at 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Ali, Aga Khan University
- Investigators
- Rabia Ali, BDS, Principal investigator, Aga Khan UniversityFarhan Raza Kahn, FCPS, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921165
- Sponsor's protocol ID
- AgaKhanUniversity
- Status last verified
- Sep 2016
- First submitted
- 23 Sep 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-hypertensive Subjects
- ClinicalTrials.gov ID
- NCT02921165
- Acronym / sponsor ID
- AgaKhanUniversity
- Conditions
- Periodontitis, Dental Caries, Hypertension
- Keywords
- tooth extraction, tooth socket healing, hypertension, rinses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: analgesic mouth rinses (dissolved Aspirin)Non hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin) |
| Group 2 | Experimental | Drug: analgesic mouth rinses (dissolved Aspirin)Hypertensive Intervention: On analgesic mouth rinses (dissolved Aspirin) |
| Group 3 | Experimental | Drug: Normal saline rinses.Non Hypertensive Intervention: On normal saline rinses. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects requiring simple tooth extraction (elevator or forceps) which were either known cases of controlled hypertension under medical treatment or confirmed non hypertensives.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analgesic mouth rinses (dissolved Aspirin)Also: water dissolved aspirin rinseGroup 1 and Group 2 patients will be prescribed analgesic mouth rinses (dissolved Aspirin) twice daily along with the standard prescription of analgesics and antibiotics. | Drug | Group 1, Group 2 |
| Normal saline rinses.Also: warm saline rinses, salt water rinsesNon Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics. | Drug | Group 3 |
Primary outcome
Number of participants with unhealed extraction socket
Time frame: Number of participants with unhealed extraction socket at 7th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia Ali, BDS principal investigator
Aga Khan University
Farhan Raza Kahn, FCPS study director
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing analgesic mouth rinses (dissolved Aspirin) and Normal saline rinses. in people with Periodontitis and Dental Caries, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with unhealed extraction socket (time frame: Number of participants with unhealed extraction socket at 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.