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

University of Santiago de Compostela

Status and phase: Completed; Phase 4

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

Treatments: Drug: Clorhexidine gel; Drug: Hyaluronic Acid gel; Drug: Clorhexidine-Chitosan gel; Drug: Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03188289

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 4 patient groups, including a placebo group

Placebo gel

Placebo Comparator group

Description:

The placebo gel is used by all patients on one side of the mouth and serves as a control group.

Treatment:

Drug: Placebo gel

Drug: Hyaluronic Acid gel

Drug: Clorhexidine-Chitosan gel

Drug: Clorhexidine gel

Clorhexidine gel

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo gel

Drug: Hyaluronic Acid gel

Drug: Clorhexidine-Chitosan gel

Drug: Clorhexidine gel

Clorhexidine-Chitosan gel

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo gel

Drug: Hyaluronic Acid gel

Drug: Clorhexidine-Chitosan gel

Drug: Clorhexidine gel

Hyaluronic acid gel

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo gel

Drug: Hyaluronic Acid gel

Drug: Clorhexidine-Chitosan gel

Drug: Clorhexidine gel