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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wisdom Teeth
• Oral Surgery
• Third Molar Surgery
• Bioadhesive Gel
• Suture Bacteria
• Antiseptic Gel
• Chistosan
• Clorhexidine Gel Bacteria
• Clorhexidine-chitosan
• Bacterial Growth

Interventions

Type	Name	Description
DRUG	Placebo gel	Placebo is the control group treated with a placebo gel.
DRUG	Clorhexidine gel	Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
DRUG	Clorhexidine-Chitosan gel	Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
DRUG	Hyaluronic Acid gel	Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels

Timeline

• Start date: 2014-01-20
• Primary completion: 2014-07-15
• Completion: 2014-09-10
• First posted: 2017-06-15
• Last updated: 2017-06-15