Clinical trial NCT03188289: Microbial Growth in the Suture Thread, After Application of Different Antiseptic Gels in Mandibular Third Molars Extraction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wisdom Teeth
Oral Surgery
Third Molar Surgery
Bioadhesive Gel
Suture Bacteria
Antiseptic Gel
Chistosan
Clorhexidine Gel Bacteria
Clorhexidine-chitosan
Bacterial Growth
Keywords: chitosan
clorhexidine
suture
bacteria
wisdom
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Microbiological growth on suture tread.
timeFrame: Seven days.
measure: Postoperative pain in the operated area.
timeFrame: Seven days.
measure: Degree of healing.
timeFrame: Seven days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Santiago de Compostela
name: Samuel Rodríguez Zorrilla, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
References: