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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-20

Study Completion Date

2014-09-10

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo gel

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

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

Placebo is the control group treated with a placebo gel.

Clorhexidine gel

Intervention Type DRUG

Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels

Clorhexidine-Chitosan gel

Intervention Type DRUG

Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.

Hyaluronic Acid gel

Intervention Type DRUG

Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels

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.

Group Type ACTIVE_COMPARATOR

Placebo gel

Intervention Type DRUG

Placebo is the control group treated with a placebo gel.

Clorhexidine gel

Intervention Type DRUG

Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels

Clorhexidine-Chitosan gel

Intervention Type DRUG

Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.

Hyaluronic Acid gel

Intervention Type DRUG

Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels

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.

Group Type ACTIVE_COMPARATOR

Placebo gel

Intervention Type DRUG

Placebo is the control group treated with a placebo gel.

Clorhexidine gel

Intervention Type DRUG

Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels

Clorhexidine-Chitosan gel

Intervention Type DRUG

Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.

Hyaluronic Acid gel

Intervention Type DRUG

Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels

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.

Group Type ACTIVE_COMPARATOR

Placebo gel

Intervention Type DRUG

Placebo is the control group treated with a placebo gel.

Clorhexidine gel

Intervention Type DRUG

Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels

Clorhexidine-Chitosan gel

Intervention Type DRUG

Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.

Hyaluronic Acid gel

Intervention Type DRUG

Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels

Interventions

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Placebo gel

Placebo is the control group treated with a placebo gel.

Intervention Type DRUG

Clorhexidine gel

Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels

Intervention Type DRUG

Clorhexidine-Chitosan gel

Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.

Intervention Type DRUG

Hyaluronic Acid gel

Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels

Intervention Type DRUG

Other Intervention Names

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Hyspagel 200 Bexident encías Bexident Post Oddent

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes