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NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

Primary Purpose

Alveolar Osteitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NBF
Placebo
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alveolar Osteitis focused on measuring third molar surgery, oral surgery, propolis, NBF gingival gel, post-surgical complications, clinica trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The inclusion criteria are:

  • cooperative adult patients able to fulfil the study protocol,
  • needing surgical extractions of both lower third molars,
  • with similar surgical difficulty according to Pederson scale.

Exclusion Criteria:

The exclusion criteria are

  • refuse to participate in the study,
  • failure to attend 24, 48, and 72 hours, as well as, 7 days post-surgical appointment visits,
  • smokers,
  • systemic diseases as diabetes mellitus or being immunosuppressed,
  • patients who take local or systemic antibiotics less than 3 months ago, anti-inflammatory or anticoagulant medication in the previous 4 weeks,
  • patients who require antibiotic prophylaxis,
  • pregnant or breastfeeding women,
  • patients with chronic periodontitis in active phase or
  • with history of allergies to any of the components of local anaesthetics, antibiotics, AINEs, or NBF gingival gel.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    NBF

    Placebo

    Arm Description

    Propolis Extract, Ascorbic Acid, Tocopherol Acetate, Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethyleneglycol 150, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate and Deionized Water

    Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethyleneglycol 150, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate and Deionized Water

    Outcomes

    Primary Outcome Measures

    Alveolar Osteitis: intense neuralgic pain in the post-extraction socket in the second or third postoperative day that do not disappear with analgesics beside a partially or totally disintegrated clot
    yes or no

    Secondary Outcome Measures

    Swelling: it was evaluated with a flexible metric tape measuring the facial perimeter from trago to pogonion. A first measurement was made before surgery, which was compared with the measurements taken at 24, 48 and 72 hours of the extraction.
    changes
    Trismus: it was assessed measuring the maximum opening from the inter incisive points.
    changes
    Wound healing: it was assessed with a semi-quantitative scale (good, satisfactory or insufficient).
    changes
    Post extraction pain: it was recorded using a visual analog scale, ranging from 0 (no pain) to 10 (the worst pain imaginable) at 9 pm of 7 consecutive days.
    changes
    Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients.
    number

    Full Information

    First Posted
    August 1, 2018
    Last Updated
    March 26, 2019
    Sponsor
    Universidad Complutense de Madrid
    Collaborators
    Bio Nature Essences S.L
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03641482
    Brief Title
    NBF Gingival Gel Application After Impacted Lower Third Molar Surgery
    Official Title
    Effect of NBF Gingival Gel Application in Controlling Post-surgical Complications After Impacted Lower Third Molar Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    July 15, 2017 (Actual)
    Study Completion Date
    February 20, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Complutense de Madrid
    Collaborators
    Bio Nature Essences S.L

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes

    5. Study Description

    Brief Summary
    Background: Alveolar osteitis is one of the most frequent complications after lower third molar extraction, and is usually accompanied by inflammation, pain and poor wound healing. Several local interventions have been used to reduce these complications with limited effectiveness. Purpose: To clinically evaluate the use of propolis extract, nanovitamin C and nanovitamin E gel for the prevention of surgical complications related to impacted lower third molar extraction. Methods: A randomized, triple-blind, split-mouth, pilot study is being performed in patients needing bilateral lower third molar extraction with similar surgical difficulty. Surgical extractions are randomly being performed and NBF gingival gel (TG) or placebo (PBG) are randomly being applied inside postextraction sockets by a blinded surgeon. The patients are being instructed to apply it 3 times/day in the surgical wound for 7 days. One month later, the contralateral wisdom tooth is being extracted and the opposite gel is being applied. Alveolar osteitis (AO) is being diagnosed following Blum's criteria. Swelling is being assessed by measuring the facial perimeter. Wound healing is being evaluated with a semi-quantitative scale as good, satisfactory or insufficient. Postoperative pain is being recorded using a visual analog scale (VAS) for 7 days. Analgesic pill intake is being recorded by each patient. Variables are being registered by a blinded researcher to 3M extractions at one, two, three and seven postoperative days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Osteitis
    Keywords
    third molar surgery, oral surgery, propolis, NBF gingival gel, post-surgical complications, clinica trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    split mouth design
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NBF
    Arm Type
    Active Comparator
    Arm Description
    Propolis Extract, Ascorbic Acid, Tocopherol Acetate, Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethyleneglycol 150, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate and Deionized Water
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethyleneglycol 150, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate and Deionized Water
    Intervention Type
    Drug
    Intervention Name(s)
    NBF
    Intervention Description
    Once the molar is extracted, the socket is cleaned with water, NBF gel is introduced, and the flap is closed. Then, the patients are instructed to apply NBF Gel in the surgical wound 3 times per day for 7 days after brushing their teeth. Previously they have to dry the area of the wound with gauze.
    Intervention Type
    Device
    Intervention Name(s)
    Placebo
    Intervention Description
    Once the molar is extracted, the socket is cleaned with water, placebo gel is introduced, and the flap is closed. Then, the patients are instructed to apply placebo gel in the surgical wound 3 times per day for 7 days after brushing their teeth. Previously they have to dry the area of the wound with gauze.
    Primary Outcome Measure Information:
    Title
    Alveolar Osteitis: intense neuralgic pain in the post-extraction socket in the second or third postoperative day that do not disappear with analgesics beside a partially or totally disintegrated clot
    Description
    yes or no
    Time Frame
    from baseline to 24, 48, 72 hours post intervention
    Secondary Outcome Measure Information:
    Title
    Swelling: it was evaluated with a flexible metric tape measuring the facial perimeter from trago to pogonion. A first measurement was made before surgery, which was compared with the measurements taken at 24, 48 and 72 hours of the extraction.
    Description
    changes
    Time Frame
    from baseline to 24, 48, 72 hours and 7 days post intervention
    Title
    Trismus: it was assessed measuring the maximum opening from the inter incisive points.
    Description
    changes
    Time Frame
    from baseline to 24, 48, 72 hours and 7 days post intervention
    Title
    Wound healing: it was assessed with a semi-quantitative scale (good, satisfactory or insufficient).
    Description
    changes
    Time Frame
    from baseline to 1 week post intervention
    Title
    Post extraction pain: it was recorded using a visual analog scale, ranging from 0 (no pain) to 10 (the worst pain imaginable) at 9 pm of 7 consecutive days.
    Description
    changes
    Time Frame
    from baseline to 1 week post intervention
    Title
    Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients.
    Description
    number
    Time Frame
    from baseline to 3 days post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria are: cooperative adult patients able to fulfil the study protocol, needing surgical extractions of both lower third molars, with similar surgical difficulty according to Pederson scale. Exclusion Criteria: The exclusion criteria are refuse to participate in the study, failure to attend 24, 48, and 72 hours, as well as, 7 days post-surgical appointment visits, smokers, systemic diseases as diabetes mellitus or being immunosuppressed, patients who take local or systemic antibiotics less than 3 months ago, anti-inflammatory or anticoagulant medication in the previous 4 weeks, patients who require antibiotic prophylaxis, pregnant or breastfeeding women, patients with chronic periodontitis in active phase or with history of allergies to any of the components of local anaesthetics, antibiotics, AINEs, or NBF gingival gel.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12190139
    Citation
    Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.
    Results Reference
    background
    PubMed Identifier
    23882458
    Citation
    Haraji A, Rakhshan V, Khamverdi N, Alishahi HK. Effects of intra-alveolar placement of 0.2% chlorhexidine bioadhesive gel on dry socket incidence and postsurgical pain: a double-blind split-mouth randomized controlled clinical trial. J Orofac Pain. 2013 Summer;27(3):256-62. doi: 10.11607/jop.1142.
    Results Reference
    background
    PubMed Identifier
    27475700
    Citation
    Madrazo-Jimenez M, Rodriguez-Caballero A, Serrera-Figallo MA, Garrido-Serrano R, Gutierrez-Corrales A, Gutierrez-Perez JL, Torres-Lagares D. The effects of a topical gel containing chitosan, 0,2% chlorhexidine, allantoin and despanthenol on the wound healing process subsequent to impacted lower third molar extraction. Med Oral Patol Oral Cir Bucal. 2016 Nov 1;21(6):e696-e702. doi: 10.4317/medoral.21281.
    Results Reference
    background

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    NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

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