NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

• Status: Completed
• Trial end date: 2018-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad Complutense de Madrid
• Collaborator: Bio Nature Essences S.L
• Treatments: Carboxymethylcellulose Sodium; Fluorophosphate

Criteria

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.