NBF Gingival Gel Application After Impacted Lower Third Molar Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Osteitis
• Intervention / Treatment: Drug: NBF; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NBF; 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; 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.
Placebo Comparator: Placebo; 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, 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Bio Nature Essences S.L

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 15, 2017
• Study Completion (Actual): February 20, 2018

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: propolis; oral surgery; third molar surgery; NBF gingival gel; post-surgical complications; clinica trial
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Osteitis; Dry Socket
• Other Study ID Numbers: 0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes