Third Molars ExtractionRITORNCT06880952
Effect of Post-operative Chlorhexidine on Postoperative Pain and Complications After Surgical Removal of Mandibular Third Molars
A study testing Chlorhexidine Digluconate Mouthwash without Alcohol in people with Third Molars Extraction, run by Isala at 1 site in Netherlands.
Trial summary
This study aimed to assess the impact of postoperative chlorhexidine use on pain management following mandibular third molar removal In this prospective, randomized controlled trial,130 patients who underwent mandibular third molar surgical removal were divided into two groups: one group used chlorhexidine for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Third Molars Extraction
- What is being tested?
- Chlorhexidine Digluconate Mouthwash without Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2021to 19 Aug 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults (18+) referred by their dentist for third molar removal
Who cannot join
- active pericoronitis or other infections
- planned coronectomy
- trismus
- chronic pain
- pregnancy
- known allergies to local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Post-operative Chlorhexidine on Postoperative Pain and Complications After Surgical Removal of Mandibular Third Molars: a Randomized Controlled Trial
This study aimed to assess the impact of postoperative chlorhexidine use on pain management following mandibular third molar removal
In this prospective, randomized controlled trial,130 patients who underwent mandibular third molar surgical removal were divided into two groups: one group used chlorhexidine for postoperative rinsing and the other did not rinse. Pain levels, measured using the Numeric Rating Scale (NRS), were recorded daily for the first seven days post-surgery. Paired-samples t-tests were utilized for data analysis.
- Conditions
- Third Molars Extraction
- Being tested
- Chlorhexidine Digluconate Mouthwash without Alcohol
- Keywords
- third molar, chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Digluconate Mouthwash without AlcoholOther
In the rinsing group, the patients received a bottle of 0,2% chlorhexidine
| Study group | Role | What they receive |
|---|---|---|
| Post-operative rinsing with chlorhexidine | Other | In the rinsing group, the patients received a bottle of 0,2% chlorhexidine Receives: Other: Chlorhexidine Digluconate Mouthwash without Alcohol |
| No post-operative rinsing | No intervention | Those allocated to the control group received no post-operative rinsing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after removal of third molar
The primary endpoint is the difference in the postoperative pain measured on a numerical rating scale (NRS) evaluated at seven days
Measured: 7 days after the inclusion pain was measured on a numerical rating scale
Secondary outcomes (1)
Post-operative complications
As secondary outcome measures alveolitis, foodimpaction, bleeding or infection
Measured: 7 days after the treatment the patient was seen at the outpatient clinic for clinical assessment. At this moment the number of patients with alveolitis, foodimpaction and bleeding was scored.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Sep 2021
- Primary completion24 Mar 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Third Molars ExtractionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen van der Sleen, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880952
- Sponsor's protocol ID
- 71727.075.20
- Acronym
- RITOR
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghaeminia H, Hoppenreijs TJ, Xi T, Fennis JP, Maal TJ, Berge SJ, Meijer GJ. Postoperative socket irrigation with drinking tap water reduces the risk of inflammatory complications following surgical removal of third molars: a multicenter randomized trial. Clin Oral Investig. 2017 Jan;21(1):71-83. doi: 10.1007/s00784-016-1751-1. Epub 2016 Feb 27.
PubMed 26922634
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-operative Chlorhexidine on Postoperative Pain and Complications After Surgical Removal of Mandibular Third Molars: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06880952
- Acronym / sponsor ID
- RITOR / 71727.075.20
- Conditions
- Third Molars Extraction
- Keywords
- third molar, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 18 Mar 2025 (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 study aimed to assess the impact of postoperative chlorhexidine use on pain management following mandibular third molar removal
In this prospective, randomized controlled trial,130 patients who underwent mandibular third molar surgical removal were divided into two groups: one group used chlorhexidine for postoperative rinsing and the other did not rinse. Pain levels, measured using the Numeric Rating Scale (NRS), were recorded daily for the first seven days post-surgery. Paired-samples t-tests were utilized for data analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-operative rinsing with chlorhexidine | Other | Other: Chlorhexidine Digluconate Mouthwash without AlcoholIn the rinsing group, the patients received a bottle of 0,2% chlorhexidine |
| No post-operative rinsing | No intervention | –Those allocated to the control group received no post-operative rinsing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults (18+) referred by their dentist for third molar removal
Key exclusion criteria (6 listed)
- active pericoronitis or other infections
- planned coronectomy
- trismus
- chronic pain
- pregnancy
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 |
|---|---|---|
| Chlorhexidine Digluconate Mouthwash without AlcoholIn the rinsing group, the patients received a bottle of 0,2% chlorhexidine | Other | Post-operative rinsing with chlorhexidine |
Primary outcome
Postoperative pain after removal of third molar
Time frame: 7 days after the inclusion pain was measured on a numerical rating scale
The primary endpoint is the difference in the postoperative pain measured on a numerical rating scale (NRS) evaluated at seven days
1 secondary outcome
Post-operative complications
Time frame: 7 days after the treatment the patient was seen at the outpatient clinic for clinical assessment. At this moment the number of patients with alveolitis, foodimpaction and bleeding was scored.
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 18 Mar 2025.
- Background: PubMed 26922634Ghaeminia H, Hoppenreijs TJ, Xi T, Fennis JP, Maal TJ, Berge SJ, Meijer GJ. Postoperative socket irrigation with drinking tap water reduces the risk of inflammatory complications following surgical removal of third molars: a multicenter randomized trial. Clin Oral Investig. 2017 Jan;21(1):71-83. doi: 10.1007/s00784-016-1751-1. Epub 2016 Feb 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Digluconate Mouthwash without Alcohol in people with Third Molars Extraction, run by Isala at 1 site in Netherlands.
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 6 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 18 Mar 2025. 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 Netherlands. 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?
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?
Postoperative pain after removal of third molar (time frame: 7 days after the inclusion pain was measured on a numerical rating scale). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880952, which also lists 1 linked publication.
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 18 Mar 2025.