Impacted Third Molar ToothPhase 4NCT03894722
Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
A Phase 4 study testing 0.5% concentration of PVP-I, 1 % concentration of PVP-I and 3 % concentration of PVP-I in people with Impacted Third Molar Tooth, run by Cansu Gül Koca.
Trial summary
The aim of the present study was to evaluate the effects of different concentrations of povidone iodine (PVP-I) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- 0.5% concentration of PVP-I, 1 % concentration of PVP-I and 3 % concentration of PVP-I
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2016to 9 Feb 2018
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification;
- Has no systemic disease
Who cannot join
- The use of medications that could interfere with the healing process;
- Smoking;
- Pregnancy or lactation;
- Presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth;
- Undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery;
- History of hypersensitivity to iodine;
- Has any thyroid diseases.
About this study
Official title: Effects of Polyvinylpyrrolidone Iodine Concentrations on Postoperative Trismus and Swelling Using as an Irrigation Solution During Impacted Third Molar Surgery : a Randomized Clinical Study
The aim of the present study was to evaluate the effects of different concentrations of povidone iodine (PVP-I) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Control, 0.5% concentration of PVP-I, 1 % concentration of PVP-I, 3 % concentration of PVP-I
- Keywords
- third molar surgery, povidone iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
During the third molar extraction the saline solution will be used in the control group.
0.5% concentration of PVP-IProcedure or surgery
During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.
1 % concentration of PVP-IProcedure or surgery
During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.
3 % concentration of PVP-IProcedure or surgery
During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.
| Study group | Role | What they receive |
|---|---|---|
| Group I (control; saline only) | Placebo comparator | Control Group: Intraoperative irrigation with saline solution only. Receives: Procedure: Control |
| Group II (0.5% concentration of PVP-I ) | Experimental | Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution. Receives: Procedure: 0.5% concentration of PVP-I |
| Group III (1% concentration of PVP-I) | Experimental | Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution. Receives: Procedure: 1 % concentration of PVP-I |
| Group IV (3% concentration of PVP-I) | Experimental | Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution. Receives: Procedure: 3 % concentration of PVP-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
For the assessment of facial swelling, three facial lines (in milimeters) were measured with a digital tape on the operated side using following (4) landmarks: the external canthus of the eye, the gonion angle, the lower border of the tragus, soft pogonion and the mouth commissure
Facial Lines between:
- the external canthus of the eye- the gonion angle
- the lower border of the tragus-the mouth commissure
- the lower border of the tragus- soft pogonion
Measured: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day
Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
The degree of trismus was assessed by measuring the distance between upper and lower incisal borders of the central incisors with a digital caliper.
Measured: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start3 Oct 2016
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
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 Impacted Third Molar ToothStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cansu Gül Koca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cansu Gül Koca, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894722
- Sponsor's protocol ID
- CHR: 2016-8/11
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- FDA-regulated device
- No
Publications
Yuce E, Dereci O, Altin N, Koca CE, Yazan M. Effects of different polyvinylpyrrolidone iodine concentrations on trismus and swelling following third molar surgery. J Pak Med Assoc. 2020 Dec;70(12(B)):2304-2309. doi: 10.5455/JPMA.130.
PubMed 33475533
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Polyvinylpyrrolidone Iodine Concentrations on Postoperative Trismus and Swelling Using as an Irrigation Solution During Impacted Third Molar Surgery : a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03894722
- Acronym / sponsor ID
- CHR: 2016-8/11
- Conditions
- Impacted Third Molar Tooth
- Keywords
- third molar surgery, povidone iodine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cansu Gül KocaUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 28 Mar 2019 (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.
The aim of the present study was to evaluate the effects of different concentrations of povidone iodine (PVP-I) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (control; saline only) | Placebo comparator | Procedure: ControlControl Group: Intraoperative irrigation with saline solution only. |
| Group II (0.5% concentration of PVP-I ) | Experimental | Procedure: 0.5% concentration of PVP-IExperimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution. |
| Group III (1% concentration of PVP-I) | Experimental | Procedure: 1 % concentration of PVP-IExperimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution. |
| Group IV (3% concentration of PVP-I) | Experimental | Procedure: 3 % concentration of PVP-IExperimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification;
- Has no systemic disease
Key exclusion criteria (7 listed)
- The use of medications that could interfere with the healing process;
- Smoking;
- Pregnancy or lactation;
- Presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth;
- Undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery;
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 |
|---|---|---|
| ControlDuring the third molar extraction the saline solution will be used in the control group. | Procedure or surgery | Group I (control; saline only) |
| 0.5% concentration of PVP-IDuring the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group. | Procedure or surgery | Group II (0.5% concentration of PVP-I ) |
| 1 % concentration of PVP-IDuring the third molar extraction 1 % concentration of PVP-I solution will be used in the test group. | Procedure or surgery | Group III (1% concentration of PVP-I) |
| 3 % concentration of PVP-IDuring the third molar extraction 3 % concentration of PVP-I solution will be used in the test group. | Procedure or surgery | Group IV (3% concentration of PVP-I) |
Primary outcome
Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
Time frame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day
For the assessment of facial swelling, three facial lines (in milimeters) were measured with a digital tape on the operated side using following (4) landmarks: the external canthus of the eye, the gonion angle, the lower border of the tragus, soft pogonion and the mouth commissure Facial Lines between: 1. the external canthus of the eye- the gonion angle 2. the lower border of the tragus-the mouth commissure 3. the lower border of the tragus- soft pogonion
Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
Time frame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.
The degree of trismus was assessed by measuring the distance between upper and lower incisal borders of the central incisors with a digital caliper.
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 Mar 2019.
- Derived from this study: PubMed 33475533Yuce E, Dereci O, Altin N, Koca CE, Yazan M. Effects of different polyvinylpyrrolidone iodine concentrations on trismus and swelling following third molar surgery. J Pak Med Assoc. 2020 Dec;70(12(B)):2304-2309. doi: 10.5455/JPMA.130.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5% concentration of PVP-I, 1 % concentration of PVP-I and 3 % concentration of PVP-I in people with Impacted Third Molar Tooth, run by Cansu Gül Koca.
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 7 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 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery) (time frame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day). The study lists 2 primary outcomes in all. 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 NCT03894722, 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 28 Mar 2019.