NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

Universidad Complutense de Madrid

Status: Completed

Conditions: Alveolar Osteitis

Treatments: Device: Placebo; Drug: NBF

Study type: Interventional

Funder types: Other

Identifiers

NCT03641482

0002

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 2 patient groups, including a placebo group

NBF

Active Comparator group

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

Treatment:

Drug: NBF

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo