Tooth Extraction Site HealingEarly Phase 1NCT03130153
Topical Analgesic Versus Saline Mouth Rinses in Post Extraction Healing
A Early Phase 1 study testing Aspirin Powder and Normal saline in people with Tooth Extraction Site Healing, run by Aga Khan University at 1 site in Pakistan.
Trial summary
There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to orally administered analgesic is questionable. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Tooth Extraction Site Healing
- What is being tested?
- Aspirin Powder and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2016to 31 Dec 2017
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carious, periodontally mobile, traumatized or broken down teeth needing extraction
- Age 20-70 years, both genders
Who cannot join
- Diabetes
- Osteoporosis, metabolic bone disease etc.
- Radiation therapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Topical Analgesic With Saline Rinses in Post Extraction Healing Among Hypertensive and Non-Hypertensive Patients
There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.
Read the detailed description
Objective: To compare the post dental extraction healing among subjects who took simple analgesic tablets dissolved in water versus those who used saline rinses post operatively.
Methods: A study will be done among patients who underwent dental extractions at AKHSP dental clinic, Karachi, Pakistan. Carious, periodontally mobile, traumatized or broken down teeth among 20-70 years old in either gender will be included.
In addition to the routine prescription of antibiotics and oral analgesics, the hypertensive subjects (n=20) will be advised to take dissolved Aspirin tablet as an oral care while non-hypertensive will be divided into two sub groups (n=20 each), advised saline mouth rinses or dissolved Aspirin for 5 days, respectively.
The outcome (healing of the extraction socket) will be evaluated 7 days from the day of extraction on an ordinal scale.
- Conditions
- Tooth Extraction Site Healing
- Being tested
- Aspirin Powder, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin PowderDrug
Also called Acetyl salicylic acid
Aspirin powder to be dissolved in water and to be used as mouthwash twice daily for 7 days after tooth extraction.
Normal salineDrug
Also called 0.9% NaCl, Saline
Normal saline to be used as mouthwash twice daily for 7 days after tooth extraction among non-hypertensive subjects.
| Study group | Role | What they receive |
|---|---|---|
| hypertensives on Aspirin mouthwash | Experimental | Not described Receives: Drug: Aspirin Powder |
| non-hypertensives on Aspirin mouthwash | Active comparator | Not described Receives: Drug: Aspirin Powder |
| hypertensives on Saline mouthwash | Active comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the extraction socket
- = "healed or healing well"
- = "incomplete healing but progressing"
- = "poorly healed open margins and readily bleeding"
Measured: Seven days from the day of extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Jan 2016
- Primary completion15 Jul 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Site HealingStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farhan Raza Khan, Aga Khan University
- Investigators
- Farhan R Khan, BDS MS FCPS, Study director, AKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130153
- Sponsor's protocol ID
- 3425-Sur-ERC-14
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2017
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. 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 Patients
- ClinicalTrials.gov ID
- NCT03130153
- Acronym / sponsor ID
- 3425-Sur-ERC-14
- Conditions
- Tooth Extraction Site Healing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Apr 2017 (actual)
- 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.
There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.
Detailed description
Objective: To compare the post dental extraction healing among subjects who took simple analgesic tablets dissolved in water versus those who used saline rinses post operatively.
Methods: A study will be done among patients who underwent dental extractions at AKHSP dental clinic, Karachi, Pakistan. Carious, periodontally mobile, traumatized or broken down teeth among 20-70 years old in either gender will be included.
In addition to the routine prescription of antibiotics and oral analgesics, the hypertensive subjects (n=20) will be advised to take dissolved Aspirin tablet as an oral care while non-hypertensive will be divided into two sub groups (n=20 each), advised saline mouth rinses or dissolved Aspirin for 5 days, respectively.
The outcome (healing of the extraction socket) will be evaluated 7 days from the day of extraction on an ordinal scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hypertensives on Aspirin mouthwash | Experimental | Drug: Aspirin Powder |
| non-hypertensives on Aspirin mouthwash | Active comparator | Drug: Aspirin Powder |
| hypertensives on Saline mouthwash | Active comparator | Drug: Normal saline |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Carious, periodontally mobile, traumatized or broken down teeth needing extraction
- Age 20-70 years, both genders
Key exclusion criteria (3 listed)
- Diabetes
- Osteoporosis, metabolic bone disease etc.
- Radiation therapy or chemotherapy.
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 |
|---|---|---|
| Aspirin PowderAlso: Acetyl salicylic acidAspirin powder to be dissolved in water and to be used as mouthwash twice daily for 7 days after tooth extraction. | Drug | hypertensives on Aspirin mouthwash, non-hypertensives on Aspirin mouthwash |
| Normal salineAlso: 0.9% NaCl, SalineNormal saline to be used as mouthwash twice daily for 7 days after tooth extraction among non-hypertensive subjects. | Drug | hypertensives on Saline mouthwash |
Primary outcome
Healing of the extraction socket
Time frame: Seven days from the day of extraction
1. = "healed or healing well" 2. = "incomplete healing but progressing" 3. = "poorly healed open margins and readily bleeding"
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 28 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Tooth Extraction Site Healing
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Enrolling by invitation
Biomaterials Exposed to Oral Environment: Which One is the Appropriate Option?
Tooth Extraction Site Healing, Alveolar Ridge Preservation
Recruiting
Volumetric Efficacy of Alveolar Ridge Preservation
Alveolar Ridge Preservation, Tooth Loss
RecruitingEarly Phase 1
Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction
Tooth Extraction, Tooth Extraction Site Healing
RecruitingEarly Phase 1
Assessment of the Impact of Neobone® (Biphasic Calcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction
Tooth Extraction Site Healing, Alveolar Ridge Preservation
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.
Farhan R Khan, BDS MS FCPS study director
AKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin Powder and Normal saline in people with Tooth Extraction Site Healing, run by Aga Khan University at 1 site in Pakistan.
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 2 inclusion and 3 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 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Healing of the extraction socket (time frame: Seven days from the day of extraction). 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 28 Jun 2018.