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NCT Number: NCT03188289

Microbial Growth in the Suture Thread, After 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.

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Key information

Conditions

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

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Gel

Drug

Placebo is the control group treated with a placebo gel.

Other names: Hyspagel 200

Clorhexidine gel

Drug

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

Other names: Bexident encías

Clorhexidine-Chitosan gel

Drug

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

Other names: Bexident Post

Hyaluronic Acid gel

Drug

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

Other names: Oddent

Primary outcomes

  1. 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.

  2. 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.

  3. 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:

    • - Erithymatous surgical zone and with signs of inflammation and infection.
    • - Erythematous surgical site without signs of infection.
    • -Surgical zone of normal color and beginning of epithelization.
    • -Surgical zone of normal color and advanced epithelization.

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 15, 2017
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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