Alveolar Osteitis
Conditions
Keywords
third molar surgery, oral surgery, propolis, NBF gingival gel, post-surgical complications, clinica trial
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.
Interventions
DRUGNBF
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.
DEVICEPlacebo
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.
Sponsors
Bio Nature Essences S.L
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
split mouth design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | from baseline to 24, 48, 72 hours post intervention | yes or no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients. | from baseline to 3 days post intervention | number |
| 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. | from baseline to 24, 48, 72 hours and 7 days post intervention | changes |
| Trismus: it was assessed measuring the maximum opening from the inter incisive points. | from baseline to 24, 48, 72 hours and 7 days post intervention | changes |
| Wound healing: it was assessed with a semi-quantitative scale (good, satisfactory or insufficient). | from baseline to 1 week post intervention | 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. | from baseline to 1 week post intervention | changes |
Outcome results
None listed