Alveolitis of JawPhase 4AITSNCT03741894
Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
A Phase 4 study testing Iodoform, Wound closure using sutures and Chlorhexidine in people with Alveolitis of Jaw and Alveoli, Teeth; Inflammation, run by University of Pecs at 1 site in Hungary.
Trial summary
In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolitis of Jaw, Alveoli, Teeth; Inflammation, Dry Socket
- What is being tested?
- Iodoform, Wound closure using sutures and Chlorhexidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2018to 30 Sep 2021
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pell-Gregory II/B impaction
- mesioangular impactions
- tooth sectioning is not necessary for removal
- without local infection of third molar
Who cannot join
- no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillofacial Surgery, University of Pécs
Pécs, 7621
Jozsef Szalma, DMD, PhD, +3672535924, drszalma@freemail.hu
Jozsef Szalma, DMD, PhD
About this study
In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.
- Being tested
- Iodoform, Wound closure using sutures, Chlorhexidine
- Keywords
- alveolitis, iodoform, chlorhexidine, minor complications
- Medical subject headings
- Dry Socket, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IodoformDrug
Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture placements for a week.
Wound closure using suturesOther
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
ChlorhexidineDrug
Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
| Study group | Role | What they receive |
|---|---|---|
| Primary wound closure | Placebo comparator | Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only. Receives: Other: Wound closure using sutures |
| Iodoform and wound closure | Experimental | Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week. Receives: Drug: Iodoform; Other: Wound closure using sutures |
| Chlorhexidine and wound closure | Experimental | Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements. Receives: Other: Wound closure using sutures; Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minor postoperative complications (trismus)
Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).
Measured: day of surgery, 3rd, 7th postoperative days
Change in minor postoperative complications (oedema)
measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).
Measured: day of surgery, 3rd, 7th postoperative days
Change in minor postoperative complications (pain)
Measuring level of pain in Visual Analog Scale (minimum score is 0 which represents no pain, maximum score is 10 which shows the worst pain) postoperatively
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Change in necessity of postoperatively taken analgesics
Registering dose of active agent of taken analgesics in milligrams .
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Change in necessity of postoperatively taken analgesics
Registering number of daily repeats of taken analgesics.
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolitis of JawStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balazs Soos, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741894
- Sponsor's protocol ID
- 7065-PTE 2018.
- Acronym
- AITS
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
- ClinicalTrials.gov ID
- NCT03741894
- Acronym / sponsor ID
- AITS / 7065-PTE 2018.
- Keywords
- alveolitis, iodoform, chlorhexidine, minor complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 15 Nov 2018 (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.
In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Primary wound closure | Placebo comparator | Other: Wound closure using suturesRoutine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only. |
| Iodoform and wound closure | Experimental | Drug: Iodoform, Other: Wound closure using suturesPatients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week. |
| Chlorhexidine and wound closure | Experimental | Other: Wound closure using sutures, Drug: ChlorhexidineExtraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pell-Gregory II/B impaction
- mesioangular impactions
- tooth sectioning is not necessary for removal
- without local infection of third molar
Key exclusion criteria (1 listed)
- no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)
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 |
|---|---|---|
| IodoformPatients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture placements for a week. | Drug | Iodoform and wound closure |
| Wound closure using suturesRoutine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only. | Other | Chlorhexidine and wound closure, Iodoform and wound closure, Primary wound closure |
| ChlorhexidineExtraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements. | Drug | Chlorhexidine and wound closure |
Primary outcome
Change in minor postoperative complications (trismus)
Time frame: day of surgery, 3rd, 7th postoperative days
Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).
Change in minor postoperative complications (oedema)
Time frame: day of surgery, 3rd, 7th postoperative days
measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).
Change in minor postoperative complications (pain)
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Measuring level of pain in Visual Analog Scale (minimum score is 0 which represents no pain, maximum score is 10 which shows the worst pain) postoperatively
Change in necessity of postoperatively taken analgesics
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Registering dose of active agent of taken analgesics in milligrams .
Change in necessity of postoperatively taken analgesics
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Registering number of daily repeats of taken analgesics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Department of Oral and Maxillofacial Surgery, University of Pécs
Pécs, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iodoform, Wound closure using sutures and Chlorhexidine in people with Alveolitis of Jaw and Alveoli, Teeth; Inflammation, run by University of Pecs at 1 site in Hungary.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Nov 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 Hungary. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in minor postoperative complications (trismus) (time frame: day of surgery, 3rd, 7th postoperative days). The study lists 5 primary outcomes in all. 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 15 Nov 2018.