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Completed

NCT Number: NCT03641482

NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

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.

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Key information

Conditions

Alveolar Osteitis Dry Socket Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

NBF

Drug

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.

PLACEBO

Device

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 outcomes

  1. 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

    Time frame: from baseline to 24, 48, 72 hours post intervention

    yes or no

Secondary outcomes

  1. 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.

    Time frame: from baseline to 24, 48, 72 hours and 7 days post intervention

    changes

  2. Trismus: it was assessed measuring the maximum opening from the inter incisive points.

    Time frame: from baseline to 24, 48, 72 hours and 7 days post intervention

    changes

  3. Wound healing: it was assessed with a semi-quantitative scale (good, satisfactory or insufficient).

    Time frame: from baseline to 1 week post intervention

    changes

  4. 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.

    Time frame: from baseline to 1 week post intervention

    changes

  5. Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients.

    Time frame: from baseline to 3 days post intervention

    number

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Bio Nature Essences S.L

Registry information

Official study title

Effect of NBF Gingival Gel Application in Controlling Post-surgical Complications After Impacted Lower Third Molar Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 22, 2018
Registry last updated
Mar 27, 2019

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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