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

June 14, 2017 updated by: Samuel Rodríguez Zorrilla, University of Santiago de Compostela

Randomized Clinical Trial of Microbial Growth in the Suture Thread, After the Post-surgical Application of Different Antiseptic Gels in Mandibular Third Molars Extraction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo gel
The placebo gel is used by all patients on one side of the mouth and serves as a control group.
Drug: Placebo gel
Placebo is the control group treated with a placebo gel.
Other Names:
  • Hyspagel 200
Drug: Clorhexidine gel
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
  • Bexident encías
Drug: Clorhexidine-Chitosan gel
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
  • Bexident Post
Drug: Hyaluronic Acid gel
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
  • Oddent
Active Comparator: 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.
Drug: Placebo gel
Placebo is the control group treated with a placebo gel.
Other Names:
  • Hyspagel 200
Drug: Clorhexidine gel
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
  • Bexident encías
Drug: Clorhexidine-Chitosan gel
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
  • Bexident Post
Drug: Hyaluronic Acid gel
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
  • Oddent
Active Comparator: 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.
Drug: Placebo gel
Placebo is the control group treated with a placebo gel.
Other Names:
  • Hyspagel 200
Drug: Clorhexidine gel
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
  • Bexident encías
Drug: Clorhexidine-Chitosan gel
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
  • Bexident Post
Drug: Hyaluronic Acid gel
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
  • Oddent
Active Comparator: 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.
Drug: Placebo gel
Placebo is the control group treated with a placebo gel.
Other Names:
  • Hyspagel 200
Drug: Clorhexidine gel
Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
Other Names:
  • Bexident encías
Drug: Clorhexidine-Chitosan gel
Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
Other Names:
  • Bexident Post
Drug: Hyaluronic Acid gel
Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
Other Names:
  • Oddent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiological growth on suture tread.
Time Frame: Seven days.
Microbiological growth in CFUs on the suture thread after the application of the distinct bioadhesive gels.
Seven days.
Postoperative pain in the operated area.
Time Frame: 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.
Seven days.
Degree of healing.
Time Frame: 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.
Seven days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Santiago de Compostela

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samuel Rodríguez Zorrilla, DDS,MSc, University of Santiago de Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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