An interventional study of NBF and Placebo in Alveolar Osteitis, sponsored by Universidad Complutense de Madrid. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Prevention
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.
The inclusion criteria are:
Exclusion Criteria:
The exclusion criteria are
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
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
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.
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.
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
Time frame: from baseline to 24, 48, 72 hours post intervention
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from baseline to 1 week post intervention
Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients.
number
Time frame: from baseline to 3 days post intervention
No study locations are listed for this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Complutense de Madrid