NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Alveolar Osteitis

Intervention / Treatment
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* Drug: NBF
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: split mouth design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NBF<br>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 | Drug: NBF<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Sodium-Monofluorophosphate, Silicon Dioxide, Glycerin, D-sorbitol, Polyethyleneglycol 150, Sodium Carboxymethylcellulose, Xylitol, Sterol Glycoside, Peppermint Oil, L-Menthol, Methyl Hydroxybenzoate and Deionized Water | Device: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from baseline to 24, 48, 72 hours post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from baseline to 24, 48, 72 hours and 7 days post intervention | 
| Trismus: it was assessed measuring the maximum opening from the inter incisive points. | changes | from baseline to 24, 48, 72 hours and 7 days post intervention | 
| Wound healing: it was assessed with a semi-quantitative scale (good, satisfactory or insufficient). | changes | from baseline to 1 week post intervention | 
| 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 | from baseline to 1 week post intervention | 
| Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients. | number | from baseline to 3 days post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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third molar surgery, oral surgery, propolis, NBF gingival gel, post-surgical complications, clinica trial