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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo gel | Placebo Comparator | The placebo gel is used by all patients on one side of the mouth and serves as a control group. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel | Drug | Placebo is the control group treated with a placebo gel. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Seven days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Rodríguez Zorrilla, DDS,MSc | University of Santiago de Compostela | Principal Investigator |
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| Clorhexidine gel | Drug | Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels |
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| Clorhexidine-Chitosan gel | Drug | Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels. |
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| Hyaluronic Acid gel | Drug | Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels |
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