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

NCT03188289 | Completed Phase 4 DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

chitosan; clorhexidine; suture; bacteria; wisdom

Outcome Measures

Primary Outcomes (3)

• Microbiological growth on suture tread.

  Microbiological growth in CFUs on the suture thread after the application of the distinct bioadhesive gels.

  Seven days.

• 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.

• 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: 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.

  Seven days.

Study Arms (4)

Placebo gel

PLACEBO COMPARATOR

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

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

Clorhexidine gel

ACTIVE COMPARATOR

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.

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

Clorhexidine-Chitosan gel

ACTIVE COMPARATOR

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.

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

Hyaluronic acid gel

ACTIVE COMPARATOR

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.

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

Interventions

Placebo gel DRUG

Placebo is the control group treated with a placebo gel.

Also known as: Hyspagel 200

Clorhexidine gel; Clorhexidine-Chitosan gel; Hyaluronic acid gel; Placebo gel

Clorhexidine gel DRUG

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

Also known as: Bexident encías

Clorhexidine gel; Clorhexidine-Chitosan gel; Hyaluronic acid gel; Placebo gel

Clorhexidine-Chitosan gel DRUG

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

Also known as: Bexident Post

Clorhexidine gel; Clorhexidine-Chitosan gel; Hyaluronic acid gel; Placebo gel

Hyaluronic Acid gel DRUG

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

Also known as: Oddent

Clorhexidine gel; Clorhexidine-Chitosan gel; Hyaluronic acid gel; Placebo gel

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Officials

• Samuel Rodríguez Zorrilla, DDS,MSc

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc.

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 15, 2017
• Study Start: January 20, 2014
• Primary Completion: July 15, 2014
• Study Completion: September 10, 2014
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share