Microbial Growth in the Suture Thread, After Application of Different Antiseptic Gels in Mandibular Third Molars Extraction

Oral Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188289
• Other study ID #: 001
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2017
• Last updated: June 14, 2017
• Start date: January 20, 2014
• Est. completion date: September 10, 2014

Study information

• Verified date: June 2017
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

After the surgery, different bioadhesive gels will be applied in the area of the surgical wound and we will evaluate the aforementioned parameters.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 10, 2014
• Est. primary completion date: July 15, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological growth on suture tread.	Microbiological growth in CFUs on the suture thread after the application of the distinct bioadhesive gels.	Seven days.
Primary	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.	Seven days.
Primary	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.	Seven days.