Post Operative Pain, AcuteNCT06741696
Saline At Different Temperatures After 3rd Molar Surgery
A study testing Surgical extraction and saline irrigations in people with Post Operative Pain, Acute, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This double-blind, single-center, split-mouth, randomized prospective clinical trial was conducted among 48 systemically and periodontally healthy patients who had bilaterally asymptomatic mandibular third molars. Read more about this study
- Who is it for?
- Ages Up to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Surgical extraction and saline irrigations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Oct 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 1 Patients with complicating systemic disease ( American Society of Anesthesiologists : 3- 6). 2. Patients who have second molars with severe periodontal defect or deep periodontal pocket (probing depth >4 mm). 3. Patients with poor oral hygiene. 4. Patients with a history of using analgesics 12 hours ago or antibiotics 1 month before. 5. The presence of cysts or tumors around the impacted third molar.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute of Dentistry
Rawalpindi, Punjab Province, 46000
About this study
Official title: Does Saline Irrigation At Different Temperatures Affect Pain, Edema, and Trismus After Impacted Third Molar Surgery: a Clinical Trial
This double-blind, single-center, split-mouth, randomized prospective clinical trial was conducted among 48 systemically and periodontally healthy patients who had bilaterally asymptomatic mandibular third molars.
Read the detailed description
Patients were randomly allocated into 2 groups (n = 24) according to the temperature of the saline used. In each patient, one impacted third molar was determined as the test group Trismus and swelling were evaluated on the 1st, 3rd, and 7th days postoperatively. Pain perception by visual analog scale (VAS) and the total number of analgesics taken during the 7 postoperative days were recorded. Data were analyzed using the Shapiro-Wilk test, the chi-square test, one-way analysis of variance, Duncan test, the Kruskal-Wallis test, the Dunn test, and the Friedman test (P < .05).
- Conditions
- Post Operative Pain, Acute
- Being tested
- Surgical extraction, saline irrigations
- Keywords
- 3rd molar surgery, saline irrigation at different temperatures
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extractionProcedure or surgery
saline irrigation at different temperatures
saline irrigationsProcedure or surgery
saline irrigation done after 3rd molar surgery
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | randomly selected group 1 Receives: Procedure: Surgical extraction; Procedure: saline irrigations |
| group 2 | Other | randomly selected group 2 Receives: Procedure: Surgical extraction; Procedure: saline irrigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain after 3rd molar surgery
Trismus and swelling were evaluated on the 1st, 3rd, and 7th days postoperatively. Pain perception by visual analog scale (VAS) and the total number of analgesics taken during the 7 postoperative days were recorded
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start24 Oct 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsa Razzaq, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- hafsa razzaq razzaq, BDS, Principal investigator, Armed Forces Institute of Dentistry , Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741696
- Sponsor's protocol ID
- Impacted 3rd molar
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2024
- Last updated
- 19 Dec 2024
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Saline Irrigation At Different Temperatures Affect Pain, Edema, and Trismus After Impacted Third Molar Surgery: a Clinical Trial
- ClinicalTrials.gov ID
- NCT06741696
- Acronym / sponsor ID
- Impacted 3rd molar
- Conditions
- Post Operative Pain, Acute
- Keywords
- 3rd molar surgery, saline irrigation at different temperatures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 Dec 2024 (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.
This double-blind, single-center, split-mouth, randomized prospective clinical trial was conducted among 48 systemically and periodontally healthy patients who had bilaterally asymptomatic mandibular third molars.
Detailed description
Patients were randomly allocated into 2 groups (n = 24) according to the temperature of the saline used. In each patient, one impacted third molar was determined as the test group Trismus and swelling were evaluated on the 1st, 3rd, and 7th days postoperatively. Pain perception by visual analog scale (VAS) and the total number of analgesics taken during the 7 postoperative days were recorded. Data were analyzed using the Shapiro-Wilk test, the chi-square test, one-way analysis of variance, Duncan test, the Kruskal-Wallis test, the Dunn test, and the Friedman test (P < .05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Procedure: Surgical extraction, Procedure: saline irrigationsrandomly selected group 1 |
| group 2 | Other | Procedure: Surgical extraction, Procedure: saline irrigationsrandomly selected group 2 |
Who may qualify
- Ages
- Up to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1 Patients with complicating systemic disease ( American Society of Anesthesiologists : 3- 6). 2. Patients who have second molars with severe periodontal defect or deep periodontal pocket (probing depth >4 mm). 3. Patients with poor oral hygiene. 4. Patients with a history of using analgesics 12 hours ago or antibiotics 1 month before. 5. The presence of cysts or tumors around the impacted third molar.
- -
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 |
|---|---|---|
| Surgical extractionsaline irrigation at different temperatures | Procedure or surgery | group 1, group 2 |
| saline irrigationssaline irrigation done after 3rd molar surgery | Procedure or surgery | group 1, group 2 |
Primary outcome
post operative pain after 3rd molar surgery
Time frame: 7 days
Trismus and swelling were evaluated on the 1st, 3rd, and 7th days postoperatively. Pain perception by visual analog scale (VAS) and the total number of analgesics taken during the 7 postoperative days were recorded
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- 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.
hafsa razzaq razzaq, BDS principal investigator
Armed Forces Institute of Dentistry , Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical extraction and saline irrigations in people with Post Operative Pain, Acute, run by Armed Forces Institute of Dentistry, Pakistan 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 0 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hafsa razzaq Razzaq, BDS (923074614908, hafsarazzaq799@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain after 3rd molar surgery (time frame: 7 days). 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 19 Dec 2024.