Dental Caries: Practitioners' Perspective and Rationale for Using Aceclofenac and Paracetamol Combination Treatment in its Management

Dental caries stands as a pervasive and avoidable ailment, identified as the primary contributor to oral discomfort and the loss of teeth. Dental caries can manifest as pain, and difficulties in eating, chewing, smiling, and communicating, stemming from the presence of missing, discolored, or impaired teeth.[1]

Dental caries are linked to specific bacteria, like Streptococcus Mutans, but microbiota shifts in the biofilm due to sugary conditions lead to enamel demineralization. Acid exposure causes subsurface mineral loss exceeding the surface, forming white spots and advancing to visible cavities. Early lesions can be managed preventively, while advanced cavities need treatment. [4] The stages of dental caries include the white spot stage and the cavity stage. Acids from bacteria and yeast erode tooth minerals, initially manifesting as reversible chalky white spots. Continued mineral loss results in cavities that darken over time, with the depth of colour not indicative of severity, as arrested decay can appear darkest. [1]

The signs and symptoms of dental caries include tooth pain; varying from mild to sharp pain while chewing or drinking something, visible holes or pits in teeth, discolored staining (brown, black, or white) on tooth surfaces, halitosis, and foul taste. In some cases, symptoms like fever, chills, abscess, and trismus may ensue. [1]

Dental pain is the major reason which brings a patient to a dentist. Dentists encounter challenges managing dental caries pain in children and adults, including diverse pain perceptions, dental anxiety, limited treatments, functional limitations, dental fear, and patient compliance with dental treatment. [5] Dental pain often triggers fear and anxiety due to expected discomfort during procedures, potentially leading to avoidance of necessary dental visits and worsening oral health. In an Indian survey, females and urban individuals displayed higher Fear of Dental Pain (FDP). Experiencing dental pain is correlated with lower Oral Health-Related Quality of Life (OHRQoL), indicating its negative impact on well-being for those with severe dental anxiety. [5,6,7]

NSAIDs: NSAIDs are among the most frequently prescribed agents for pain relief globally. They inhibit COX-1 and/or COX-2 enzyme pathways, curtailing prostaglandin synthesis and exhibiting anti-inflammatory, analgesic, and antipyretic effects. These include aceclofenac, diclofenac, ketorolac, piroxicam, ibuprofen, naproxen, ketoprofen, flurbiprofen, indomethacin, sulindac, etodolac, mefenamic acid, and nabumetone. [9]

Combining NSAIDs with paracetamol often provides enhanced analgesia compared to paracetamol alone, particularly in cases of acute pain following dental surgeries. [11] Combining a nonsteroidal anti-inflammatory drug (NSAID) with paracetamol yields synergistic analgesia. NSAIDs target the peripheral pathway, and paracetamol affects the central nociceptive pathway, resulting in multimodal analgesic effects.[12] Dental caries can introduce bacteria into tooth pulp via dentinal tubules, causing inflammation and pain. NSAIDs reduce inflammation by inhibiting mediators like Interleukin (IL-1β), Tumor Necrosis Factor (TNF), COX-2 enzyme, and pain-inducing prostaglandins, leading to effective pain relief. [13]

Aceclofenac, a phenylacetic acid derivative categorized as an NSAID, predominantly targets COX-2 and prostaglandin E2 (PGE2). It is effective as an anti-inflammatory, potent analgesic, and antipyretic when taken orally at 100mg twice daily; and is clinically useful for dental pain. Paracetamol (Acetaminophen) exhibits analgesic and antipyretic properties. It acts by inhibiting COX-1 and COX-2 through peroxidase functions. Paracetamol is now established as a standard analgesic and antipyretic across various age groups, effectively addressing pain, inflammation, and fever. [11,14]

Aceclofenac: Superior Efficacy in Acute Dental Pain: P. Pavithra et al conducted a randomized, double-blind trial involving 85 Indian patients with acute dental pain from irreversible pulpitis. About fifty participants meeting inclusion criteria were randomized into two groups. Group A received 400mg Ibuprofen, while Group B received 100 mg Aceclofenac. Pain intensity was assessed over intervals of 15, 30, and 45 minutes using the Visual Analog Scale (VAS) (a measurement tool to assess the magnitude or intensity of pain and discomfort). Both drugs notably reduced pain intensity, with Aceclofenac demonstrating a better analgesic effect than Ibuprofen across all time intervals (p<0.001). The study inferred that aceclofenac can be preferred for reducing dental pain. [15]

Rapid & Long-Lasting Analgesic Effect of Aceclofenac in Dental Pain: An Indian Experience: Jyothsna K et al conducted a randomized, open-label, comparative, single-center study which included 100 Indian adult patients (aged 18-60 years) to evaluate the efficacy and safety of Aceclofenac 100 mg twice a day compared to Diclofenac Sodium 50 mg three times a day. Group A received diclofenac sodium 50 mg and Group B was administered Aceclofenac 100 mg. On the day of surgery, patients were provided study drugs, and Visual Analog Scales (VAS; a measurement tool to assess the magnitude or intensity of pain and discomfort) were used to examine the pain intensity over 5 days. The pain intensity was measured after 8h post-surgery in which diclofenac showed 27% pain reduction and aceclofenac showed 40% pain reduction (P<0.05). On day 5 aceclofenac showed superior pain reduction (100%) compared to the diclofenac group (95%). The study concluded that aceclofenac has a rapid onset of action and a longer analgesic effect for reducing dental pain. [16]

Paracetamol – Conjunction Consideration with NSAIDs in Dental Pain Relief: Tom Dodson conducted a randomized, parallel-group, placebo-controlled, double-blind clinical trial of paracetamol to evaluate its effectiveness in acute dental pain reduction post-surgery. About 2048 participants were initially enrolled (1148 with paracetamol, 892 with placebo); 1968 (96%) were included in the meta-analysis (1133 with paracetamol, 835 with placebo). Paracetamol demonstrated significant pain relief compared to placebo at 4 and 6 hours. Paracetamol was effective for postoperative pain management, at higher doses, and is well-tolerated. It can be considered as a first-line choice or in conjunction with other analgesics like nonsteroidal anti-inflammatory drugs to alleviate dental pain. [17]

• Aceclofenac (NSAIDs) offers anti-inflammatory and analgesic properties. It is often prescribed at doses of 100 mg twice daily. It is well tolerated, supporting patient compliance. [14,16]
• Paracetamol functions as both an analgesic and antipyretic agent and is extensively utilized for pain management. [9,11]
• Both aceclofenac and paracetamol are COX-2 selective inhibitors that reduce pain and inflammation. While aceclofenac targets peripheral COX enzymes, paracetamol targets brain COX enzymes that reduce pain and fever. These mechanisms make them a complementary choice for combination therapy, potentially providing broader and enhanced pain relief. [10,11,12,13,14]
• The recommended dosage of the combination is Aceclofenac (100 mg) plus Paracetamol (325 mg). [9,14] is up to two times daily (18).

• Dental caries is the deterioration of dental hard tissues It gradually progresses and results from an imbalance between tooth minerals and oral biofilms.
• Dental caries can cause pain, and difficulty in eating, chewing, smiling, and communicating due to missing or damaged teeth.
• Dental pain management involves various approaches like local anesthesia, NSAIDs, paracetamol, and opioids.
• Combining NSAIDs and paracetamol enhances pain relief for dental procedures, offering effective analgesia.
• Combining aceclofenac (NSAID) and paracetamol offers enhanced pain relief due to their distinct mechanisms of action providing synergistic effects. Aceclofenac targets peripheral inflammation while paracetamol focuses on central pain perception.
• Clinical studies support the efficacy of aceclofenac and paracetamol combination therapy in reducing dental pain. Aceclofenac provides quick onset and extended pain relief, while paracetamol is effective for dental pain.
• The combination treatment of Aceclofenac plus Paracetamol offers a comprehensive approach for effectively managing dental caries-related pain through a potentially synergistic effect that can enhance pain relief and improve patient comfort. [10,11,12,13,14,17]

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12. Mohamed Amine Msolli, MD, Adel Sekma, MD, Marwa Toumia, MD, Khaoula Bel Haj Ali, MD, Mohamed Hassen Khalil, MD,Mohamed Habib Grissa, MD, Wahid Bouida, MD, Kaouthar Beltaief, MD,Asma Zorgati, MD, Mehdi Methamem, MD, Asma Belguith, MD,Riadh Boukef, MD, Hamdi Boubaker, MD and Semir Nouira, MD. Acetaminophen, Nonsteroidal Anti-inflammatory Drugs, or Combination of Both Analgesics in Acute Posttrauma Pain: A Randomized Controlled Trial. Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine, 2021;28(2), 155–163. 

13. Karthik R Mohan, Mohan Narayanan, Pethagounder Thangavel Ravikumar, Saramma M Fenn, Sabitha Gokulraj, Amirthaleka. Evaluation of NSAIDs in Acute Odontogenic Pain: A Quadriblind Study. World Journal of Dentistry 2019;10(5): 384–389. 

14. Rabia Bushra, Muhammad Harris Shoaib, Muhammad Iyad Naeem, Nousheen Aslam. ACECLOFENAC: A NEW EFFECTIVE AND SAFE NSAID. IJDDT Vol.4 No.1 January-June 2013, pp.34-42.

15. Kudaravalli Jyothsna, Narayan Deshpande and Gali Vijayalakshmi. Efficacy and Safety of Diclofenac Sodium and Aceclofenac in Controlling Post Extraction Dental Pain: A Randomised, Open Label Comparative Study. Journal Of Pharmacology And Toxicology 6(5): 541-547,2011. DOI: 10.3923/jpt.2011.541.547.

16. P.Pavithra, M. Dhanraj, Prathap Sekhar. Analgesic Effectiveness of Ibuprofen and Aceclofenac in the Management of Acute Pulpitis - A Randomized Double-Blind Trial.Int. J. Pharm. Sci. Rev. Res., 35(2), November – December 2015; Article No. 14, Pages: 70-74 

17. Dodson, T. (2007). Paracetamol is an effective drug to use for pain following oral surgery: Is paracetamol (acetaminophen) effective in controlling pain after oral surgery? Evidence-Based Dentistry, 8(3), 79–80.

18. Hifenac P. Prescribing Information Leaflet. 2015. Retrieved on 16th August, 2023