Wisdom TeethPhase 4NCT03188289
Microbial Growth in the Suture Thread, After Application of Different Antiseptic Gels in Mandibular Third Molars Extraction
A Phase 4 study testing Clorhexidine gel, Clorhexidine-Chitosan gel and Hyaluronic Acid gel in people with Wisdom Teeth and Oral Surgery, run by University of Santiago de Compostela.
Trial summary
This is a randomized clinical trial in which investigators will compare the antimicrobial effect and inducer of cicatrization as well as the degree of postoperative pain in patients who are extracted the lower third molars. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Wisdom Teeth, Oral Surgery, Third Molar Surgery
- What is being tested?
- Clorhexidine gel, Clorhexidine-Chitosan gel and Hyaluronic Acid gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2014to 10 Sep 2014
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: between 18 and 39 years.
- Good general health.
- Availability during the study.
- No current odontological treatments or foreseen during the study period.
- Acceptance and compliance with the prescribed oral hygiene instructions.
- Agreement to not used mouthwashes or toothpastes with antiseptic agents during the study period.
Who cannot join
- Use of antimicrobial mouthwashes or toothpastes during the period during which the suture remains in the mouth.
- Diabetes.
- Smoking.
- Degenerative diseases.
- Deficient oral health (cavities, periodontal disease, pathologies of the oral mucosa...).
- Wearing prosthetic or orthodontic devices.
- Amoxicillin allergy.
- Pregnant or lactating women.
About this study
Official title: Randomized Clinical Trial of Microbial Growth in the Suture Thread, After the Post-surgical Application of Different Antiseptic Gels in Mandibular Third Molars Extraction
This is a randomized clinical trial in which investigators will compare the antimicrobial effect and inducer of cicatrization as well as the degree of postoperative pain in patients who are extracted the lower third molars.
After the surgery, different bioadhesive gels will be applied in the area of the surgical wound and we will evaluate the aforementioned parameters.
Read the detailed description
Introduction: Surgical removal of the third molars is one of the most frequent procedures in oral surgery. Healing of the wound is initially sought by approximating the edges using a suturing technique. Adherence and microbiological accumulation of the suture during the period that it remains in the mouth, which can serve as a focus for odontogenic infections. The use of oral antiseptics before and after the surgery is an efficient method for microbial reduction. The purposes of this project were to evaluate the microbial growth in the suture thread on different culture means after the post-surgical application of the gels under study, while assessing the intensity of post-surgical pain and the degree of healing of the surgical wound.
Material and methods: It is a randomized and blind clinical trial. 21 patients participated (42 wisdom teeth), who consulted the unit for a surgical tooth extraction for at least the two lower wisdom teeth. The evaluated bioadhesive gels were: Chlorhexidine gel at 0.2 % (Bexident Gel Gingival®), Chlorhexidine gel at 0.2% + Chitosan (Bexident Post®) and hyaluronic acid gel (ODDENT®). A neutral water-based gel without any active ingredients was also used HISPAGEL 200® (Acofarma, Madrid, Spain) as the control agent. An assessment of the post-surgical healing, the microbiological analysis of the suture thread and the post-surgical pain was developed.
- Conditions
- Wisdom Teeth, Oral Surgery, Third Molar Surgery, Bioadhesive Gel, Suture Bacteria, Antiseptic Gel
- Being tested
- Placebo gel, Clorhexidine gel, Clorhexidine-Chitosan gel, Hyaluronic Acid gel
- Keywords
- chitosan, clorhexidine, suture, bacteria, wisdom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelDrug
Also called Hyspagel 200
Placebo is the control group treated with a placebo gel.
Clorhexidine gelDrug
Also called Bexident encías
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Clorhexidine-Chitosan gelDrug
Also called Bexident Post
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Hyaluronic Acid gelDrug
Also called Oddent
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
| Study group | Role | What they receive |
|---|---|---|
| Placebo gel | Placebo comparator | The placebo gel is used by all patients on one side of the mouth and serves as a control group. Receives: Drug: Placebo gel; Drug: Clorhexidine gel; Drug: Clorhexidine-Chitosan gel; Drug: Hyaluronic Acid gel |
| Clorhexidine gel | Active comparator | Chlorhexidine gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants. Receives: Drug: Placebo gel; Drug: Clorhexidine gel; Drug: Clorhexidine-Chitosan gel; Drug: Hyaluronic Acid gel |
| Clorhexidine-Chitosan gel | Active comparator | Clorhexidine-chitosan gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants. Receives: Drug: Placebo gel; Drug: Clorhexidine gel; Drug: Clorhexidine-Chitosan gel; Drug: Hyaluronic Acid gel |
| Hyaluronic acid gel | Active comparator | Hialuronic acid gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants. Receives: Drug: Placebo gel; Drug: Clorhexidine gel; Drug: Clorhexidine-Chitosan gel; Drug: Hyaluronic Acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological growth on suture tread.
Microbiological growth in CFUs on the suture thread after the application of the distinct bioadhesive gels.
Measured: Seven days.
Postoperative pain in the operated area.
The researchers will analyze the degree of postoperative pain patients suffered during the first postoperative week by applying one of the gels to be studied in the area of the surgical wound. To make this measurement the visual analogue pain scale will be used.
Measured: Seven days.
Degree of healing.
The degree of healing at 7 days after surgery was measured using a visual healing scale consisting of four different levels of healing status:
- - Erithymatous surgical zone and with signs of inflammation and infection.
- - Erythematous surgical site without signs of infection.
- -Surgical zone of normal color and beginning of epithelization.
- -Surgical zone of normal color and advanced epithelization.
Measured: Seven days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start20 Jan 2014
- Primary completion15 Jul 2014
- Study completion10 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wisdom TeethStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Rodríguez Zorrilla, University of Santiago de Compostela
- Investigators
- Samuel Rodríguez Zorrilla, DDS,MSc, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188289
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2017
- First submitted
- 28 May 2017
- Last updated
- 15 Jun 2017
- 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 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Microbial Growth in the Suture Thread, After the Post-surgical Application of Different Antiseptic Gels in Mandibular Third Molars Extraction
- ClinicalTrials.gov ID
- NCT03188289
- Acronym / sponsor ID
- 001
- Conditions
- Wisdom Teeth, Oral Surgery, Third Molar Surgery, Bioadhesive Gel, Suture Bacteria, Antiseptic Gel
- Keywords
- chitosan, clorhexidine, suture, bacteria, wisdom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 20 Jan 2014 (actual)
- Primary completion
- 15 Jul 2014 (actual)
- Study completion
- 10 Sep 2014 (actual)
- First posted
- 15 Jun 2017 (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 is a randomized clinical trial in which investigators will compare the antimicrobial effect and inducer of cicatrization as well as the degree of postoperative pain in patients who are extracted the lower third molars.
After the surgery, different bioadhesive gels will be applied in the area of the surgical wound and we will evaluate the aforementioned parameters.
Detailed description
Introduction: Surgical removal of the third molars is one of the most frequent procedures in oral surgery. Healing of the wound is initially sought by approximating the edges using a suturing technique. Adherence and microbiological accumulation of the suture during the period that it remains in the mouth, which can serve as a focus for odontogenic infections. The use of oral antiseptics before and after the surgery is an efficient method for microbial reduction. The purposes of this project were to evaluate the microbial growth in the suture thread on different culture means after the post-surgical application of the gels under study, while assessing the intensity of post-surgical pain and the degree of healing of the surgical wound.
Material and methods: It is a randomized and blind clinical trial. 21 patients participated (42 wisdom teeth), who consulted the unit for a surgical tooth extraction for at least the two lower wisdom teeth. The evaluated bioadhesive gels were: Chlorhexidine gel at 0.2 % (Bexident Gel Gingival®), Chlorhexidine gel at 0.2% + Chitosan (Bexident Post®) and hyaluronic acid gel (ODDENT®). A neutral water-based gel without any active ingredients was also used HISPAGEL 200® (Acofarma, Madrid, Spain) as the control agent. An assessment of the post-surgical healing, the microbiological analysis of the suture thread and the post-surgical pain was developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo gel | Placebo comparator | Drug: Placebo gel, Drug: Clorhexidine gel, Drug: Clorhexidine-Chitosan gel, Drug: Hyaluronic Acid gelThe placebo gel is used by all patients on one side of the mouth and serves as a control group. |
| Clorhexidine gel | Active comparator | Drug: Placebo gel, Drug: Clorhexidine gel, Drug: Clorhexidine-Chitosan gel, Drug: Hyaluronic Acid gelChlorhexidine gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants. |
| Clorhexidine-Chitosan gel | Active comparator | Drug: Placebo gel, Drug: Clorhexidine gel, Drug: Clorhexidine-Chitosan gel, Drug: Hyaluronic Acid gelClorhexidine-chitosan gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants. |
| Hyaluronic acid gel | Active comparator | Drug: Placebo gel, Drug: Clorhexidine gel, Drug: Clorhexidine-Chitosan gel, Drug: Hyaluronic Acid gelHialuronic acid gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: between 18 and 39 years.
- Good general health.
- Availability during the study.
- No current odontological treatments or foreseen during the study period.
- Acceptance and compliance with the prescribed oral hygiene instructions.
Key exclusion criteria (8 listed)
- Use of antimicrobial mouthwashes or toothpastes during the period during which the suture remains in the mouth.
- Diabetes.
- Smoking.
- Degenerative diseases.
- Deficient oral health (cavities, periodontal disease, pathologies of the oral mucosa...).
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 |
|---|---|---|
| Placebo gelAlso: Hyspagel 200Placebo is the control group treated with a placebo gel. | Drug | Clorhexidine gel, Clorhexidine-Chitosan gel, Hyaluronic acid gel, Placebo gel |
| Clorhexidine gelAlso: Bexident encíasClorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels | Drug | Clorhexidine gel, Clorhexidine-Chitosan gel, Hyaluronic acid gel, Placebo gel |
| Clorhexidine-Chitosan gelAlso: Bexident PostClorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels. | Drug | Clorhexidine gel, Clorhexidine-Chitosan gel, Hyaluronic acid gel, Placebo gel |
| Hyaluronic Acid gelAlso: OddentHyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels | Drug | Clorhexidine gel, Clorhexidine-Chitosan gel, Hyaluronic acid gel, Placebo gel |
Primary outcome
Microbiological growth on suture tread.
Time frame: Seven days.
Microbiological growth in CFUs on the suture thread after the application of the distinct bioadhesive gels.
Postoperative pain in the operated area.
Time frame: Seven days.
The researchers will analyze the degree of postoperative pain patients suffered during the first postoperative week by applying one of the gels to be studied in the area of the surgical wound. To make this measurement the visual analogue pain scale will be used.
Degree of healing.
Time frame: Seven days.
The degree of healing at 7 days after surgery was measured using a visual healing scale consisting of four different levels of healing status: 1. - Erithymatous surgical zone and with signs of inflammation and infection. 2. - Erythematous surgical site without signs of infection. 3. -Surgical zone of normal color and beginning of epithelization. 4. -Surgical zone of normal color and advanced epithelization.
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 15 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Wisdom Teeth
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Periodontal Defect
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A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
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Not yet recruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
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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.
Samuel Rodríguez Zorrilla, DDS,MSc principal investigator
University of Santiago de Compostela
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clorhexidine gel, Clorhexidine-Chitosan gel and Hyaluronic Acid gel in people with Wisdom Teeth and Oral Surgery, run by University of Santiago de Compostela.
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 6 inclusion and 8 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 15 Jun 2017. 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?
Microbiological growth on suture tread. (time frame: Seven days.). The study lists 3 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 Jun 2017.