- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188289
Microbial Growth in the Suture Thread, After Application of Different Antiseptic Gels in Mandibular Third Molars Extraction
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo gel
The placebo gel is used by all patients on one side of the mouth and serves as a control group.
|
Placebo is the control group treated with a placebo gel.
Other Names:
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
|
Active Comparator: Clorhexidine gel
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.
|
Placebo is the control group treated with a placebo gel.
Other Names:
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
|
Active Comparator: Clorhexidine-Chitosan gel
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.
|
Placebo is the control group treated with a placebo gel.
Other Names:
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
|
Active Comparator: Hyaluronic acid gel
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.
|
Placebo is the control group treated with a placebo gel.
Other Names:
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Seven days.
|
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.
|
Seven days.
|
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:
|
Seven days.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Samuel Rodríguez Zorrilla, DDS,MSc, University of Santiago de Compostela
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Immunologic Factors
- Protective Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Adjuvants, Immunologic
- Hemostatics
- Coagulants
- Chelating Agents
- Sequestering Agents
- Viscosupplements
- Hyaluronic Acid
- Chitosan
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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