Efficacy of chlorhexidine, dexpanthenol, allantoin and chitosan gel in comparison with bicarbonate oral rinse in controlling post-interventional inflammation, pain and cicatrization in subjects undergoing dental surgery

Abstract

Introduction:

Reducing post-interventional inflammation and pain in odontostomatological surgery procedures, such as tooth extractions, implants or oral biopsies is a relevant clinical goal. Chlorhexidine oral rinse is commonly used with this aim. Recently a new product containing chlorhexidine, dexpanthenol, allantoin and chitosan (Bexident Post [BP]) in a gel formulation has been developed. We evaluated the efficacy of BP in controlling postsurgical inflammation and pain and in promoting cicatrization in subjects undergoing molar extractions.

Subjects and methods:

We conducted a prospective sequential cross-over, randomized controlled study in patients undergoing surgical removal of at least two impacted mandibular third molars (teeth numbers 38 and 48) (numbers 17 and 32 in the Universal Tooth Numbering System), in two separate sessions, to determine the effect of BP in comparison with bicarbonate (BC) oral rinse (one spoonful in 200 ml of water), both used three times daily. Each subject utilized both products in a randomized sequential manner after each tooth extraction. Primary outcomes of the study were post-procedure pain and inflammation. Secondary outcomes were analgesic pill rescue use (metamizole 1 cap every 8 hours if needed) and an assessor-blinded evaluation of cicatrization with a semi-quantitative scale (good, satisfactory and insufficient). Post-procedure pain was assessed 6 hours after tooth extraction and for seven consecutive days by means of a 10 cm visual analogue scale (VAS) (from 0: no pain to 10: extreme pain). The extent of inflammation was evaluated through metric measurements of facial perimeter using standardized anatomical reference points.

Results:

A total of 47 patients (22 men and 25 women; mean age 34 years) were enrolled with a total of 94 molars extracted. Nineteen subjects applied BC as the first sequential treatment and 28 BP as the first. Before surgery no mean differences in the two treatments in inflammation measurements were observed. After surgery mean VAS pain score was similar between the two treatments in the first 6 hours (VAS score = 6.5). A marked progressive reduction in pain intensity with the use of BP was observed throughout the treatment period in comparison with BC (7 day mean scores 3.7 vs. 5.3; p = 0.0001). BP was superior to BC in reducing inflammation with −50% of the inflammation-related measurement (6 mm vs. 12 mm; p = 0.0001). Analgesic pill consumption was lower with BP in comparison with BC (13 pills vs. 24; p < 0.05). Cicatrization was scored ‘good’ in a higher percentage of subjects during BP use (64%) in comparison with the BC group (13%) (p = 0.0001). No serious side effects were reported with either treatment regimen.

Conclusion:

In this trial BP performed better than BC in controlling pain and inflammation in subjects undergoing dental surgery, reducing the consumption of analgesics and favoring better cicatrization.

Keywords: :

• Chitosan
• Chlorhexidine
• Controlled clinical trial
• Dexpanthenol
• Oral rinse
• Oral surgery

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Corrigendum

Transparency

Declaration of funding

The study was partially funded by an unrestricted grant from Isdin Barcelona (Spain). Study drugs were supplied by Isdin. The company was not involved in the collection, input, analysis and interpretation of the data.

Author contributions: J.L.-L. had the original study idea and participated in its design and coordination. M.M. helped regarding study design, protocol definition and manuscript final version. J.L.-L. carried out patient selection and visits. All authors read and approved the final manuscript.

Declaration of financial/other relationships

M.M. has disclosed that he is an employee of Isdin. J.L.-L., E.J.-P., B.G.-N., E.J.-S., and A.E.-D. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewer 1 has disclosed that he has received grants from Pfizer and McNeil Pharmaceuticals. Peer reviewer 2 has no relevant financial or other relationships to disclose.

Notes

*Bexident Post is a registered trademark of Isdin Barcelona, Spain

*Bexident Post is a registered trademark of Isdin Barcelona, Spain