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

Phase 4

Completed

• Conditions: Wisdom Teeth; Oral Surgery; Antiseptic Gel; Clorhexidine Gel Bacteria; Bioadhesive Gel; Clorhexidine-chitosan; Third Molar Surgery; Chistosan; Suture Bacteria; Bacterial Growth
• Interventions: Drug: Placebo gel; Drug: Clorhexidine gel; Drug: Clorhexidine-Chitosan gel; Drug: Hyaluronic Acid gel

• Registration Number: NCT03188289
• Lead Sponsor: University of Santiago de Compostela

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.

Study Timeline

• Study Start: 2014-01-20
• Primary Completion: 2014-07-15
• Study Completion: 2014-09-10
• Study First Submitted: 2017-05-28
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-14
• Last Update Submitted: 2017-06-14
• Study First Posted: 2017-06-15
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo gel	Hyaluronic Acid gel	The placebo gel is used by all patients on one side of the mouth and serves as a control group.
Placebo gel	Placebo gel	The placebo gel is used by all patients on one side of the mouth and serves as a control group.
Clorhexidine gel	Placebo 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.
Clorhexidine gel	Clorhexidine-Chitosan 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.
Clorhexidine gel	Hyaluronic Acid 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 gel	Clorhexidine-Chitosan gel	The placebo gel is used by all patients on one side of the mouth and serves as a control group.
Placebo gel	Clorhexidine gel	The placebo gel is used by all patients on one side of the mouth and serves as a control group.
Hyaluronic acid gel	Placebo 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.
Clorhexidine gel	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.
Clorhexidine-Chitosan gel	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.
Clorhexidine-Chitosan gel	Hyaluronic Acid 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.
Clorhexidine-Chitosan gel	Clorhexidine 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.
Hyaluronic acid gel	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.
Clorhexidine-Chitosan gel	Placebo 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.
Hyaluronic acid gel	Clorhexidine 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.
Hyaluronic acid gel	Clorhexidine-Chitosan 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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain in the operated area.	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.
Microbiological growth on suture tread.	Seven days.	Microbiological growth in CFUs on the suture thread after the application of the distinct bioadhesive gels.
Degree of healing.	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: 1. - Erithymatous surgical zone and with signs of inflammation and infection.; 2. - Erythematous surgical site without signs of infection.; 3. -Surgical zone of normal color and beginning of epithelization.; 4. -Surgical zone of normal color and advanced epithelization.