Surgical Blood LossNCT04143373
Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery
A study testing warm saline irrigation in people with Surgical Blood Loss and Third Molar, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Blood Loss, Third Molar
- What is being tested?
- warm saline irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2017to 10 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a candidate for bilateral mandibular third molar surgery
- Both mandibular third molars must have a similar inclination to the second molar
- Both mandibular third molars must have same Pell \& Gregory's classification
Who cannot join
- Presence of any systemic condition or using any type of medication
- History of allergy to local anesthetic (LA) solutions
- Patients with an active gag reflex
- Pregnant and post-menopause women
- Patients with pericoronitis or any local inflammation
Trial locations and contacts
1 site in 1 country.
Iran1 site
department of oral and maxillofacial surgery, school of dentistry, Tehran university of medical sciences,
Tehran
About this study
Official title: The Effect of Warm Saline Irrigation on the Amount of Bleeding in Impacted Mandibular Third Molar Surgery: a Split-mouth Single-blinded Randomized Controlled Clinical Trial
The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively.
Read the detailed description
The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively. For this purpose, 40 mandibular impacted third molars will be randomly allocated to two groups and surgically removed with the abovementioned saline temperatures. Finally, the suctioned liquids and duration of the surgeries will be carefully measured and compared between both sides.
- Conditions
- Surgical Blood Loss, Third Molar
- Being tested
- warm saline irrigation
- Keywords
- Warm Saline
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warm saline irrigationProcedure or surgery
The objective of this research was to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Warm saline | Experimental | this site was irrigated during impacted mandibular third molar surgery, with normal saline of 37 ± 1 ° C as for the experimental side. Receives: Procedure: warm saline irrigation |
| Room temperature saline | No intervention | this site was irrigated during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C as for the control side. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Bleeding in Cubic Centimetre
both sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared
Measured: Intraoperatively, up to 30 minutes
Secondary outcomes (1)
Duration of the Surgery in Minutes
both sides will be irrigated with 200cc of saline and the duration of the surgeries will be carefully measured and compared between both sides
Measured: Intraoperatively, up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Oct 2017
- Primary completion1 Dec 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Blood LossStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahboobe Hasheminasab, DMD, Study director, School of dentistry, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143373
- Sponsor's protocol ID
- TehranUMS thesis #6234
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2019
- Last updated
- 7 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Warm Saline Irrigation on the Amount of Bleeding in Impacted Mandibular Third Molar Surgery: a Split-mouth Single-blinded Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04143373
- Acronym / sponsor ID
- TehranUMS thesis #6234
- Conditions
- Surgical Blood Loss, Third Molar
- Keywords
- Warm Saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Posted 7 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively.
Detailed description
The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively. For this purpose, 40 mandibular impacted third molars will be randomly allocated to two groups and surgically removed with the abovementioned saline temperatures. Finally, the suctioned liquids and duration of the surgeries will be carefully measured and compared between both sides.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm saline | Experimental | Procedure: warm saline irrigationthis site was irrigated during impacted mandibular third molar surgery, with normal saline of 37 ± 1 ° C as for the experimental side. |
| Room temperature saline | No intervention | –this site was irrigated during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C as for the control side. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being a candidate for bilateral mandibular third molar surgery
- Both mandibular third molars must have a similar inclination to the second molar
- Both mandibular third molars must have same Pell \& Gregory's classification
Key exclusion criteria (5 listed)
- Presence of any systemic condition or using any type of medication
- History of allergy to local anesthetic (LA) solutions
- Patients with an active gag reflex
- Pregnant and post-menopause women
- Patients with pericoronitis or any local inflammation
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 |
|---|---|---|
| warm saline irrigationThe objective of this research was to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively. | Procedure or surgery | Warm saline |
Primary outcome
Amount of Bleeding in Cubic Centimetre
Time frame: Intraoperatively, up to 30 minutes
both sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared
1 secondary outcome
Duration of the Surgery in Minutes
Time frame: Intraoperatively, up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mahboobe Hasheminasab, DMD study director
School of dentistry, Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warm saline irrigation in people with Surgical Blood Loss and Third Molar, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 5 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 7 May 2020. 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 Iran. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amount of Bleeding in Cubic Centimetre (time frame: Intraoperatively, up to 30 minutes). 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 7 May 2020.