NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

NCT03641482 | Completed FDA Device

• 1 other identifier: 0002
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Osteitis

Keywords

third molar surgery; oral surgery; propolis; NBF gingival gel; post-surgical complications; clinica trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Wound healing: it was assessed with a semi-quantitative scale (good, satisfactory or insufficient).

  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.

  from baseline to 1 week post intervention

• Number of rescue analgesic pills consumption: recorded for the first 3 days by the patients.

  from baseline to 3 days post intervention

Study Arms (2)

NBF

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

NBF DRUG

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.

NBF

Placebo DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Bio Nature Essences S.L: collaborator

Related Publications (3)

• Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.

  PMID: 12190139 BACKGROUND

• Haraji A, Rakhshan V, Khamverdi N, Alishahi HK. Effects of intra-alveolar placement of 0.2% chlorhexidine bioadhesive gel on dry socket incidence and postsurgical pain: a double-blind split-mouth randomized controlled clinical trial. J Orofac Pain. 2013 Summer;27(3):256-62. doi: 10.11607/jop.1142.

  PMID: 23882458 BACKGROUND

• Madrazo-Jimenez M, Rodriguez-Caballero A, Serrera-Figallo MA, Garrido-Serrano R, Gutierrez-Corrales A, Gutierrez-Perez JL, Torres-Lagares D. The effects of a topical gel containing chitosan, 0,2% chlorhexidine, allantoin and despanthenol on the wound healing process subsequent to impacted lower third molar extraction. Med Oral Patol Oral Cir Bucal. 2016 Nov 1;21(6):e696-e702. doi: 10.4317/medoral.21281.

  PMID: 27475700 BACKGROUND

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: split mouth design

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2016
• Primary Completion: July 15, 2017
• Study Completion: February 20, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03