Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12‐month short‐term evaluation

Abstract This study indented to assess the clinical and radiographic assessment of Allium sativum extract as an intracanal irrigant for pulpectomy of primary molars. Ninety children with 110 teeth submitted were categorized into two groups. Clinical and radiographic success rates were checked at 3, 6, and 12 months. Qui‐square test at a level of significance was ˂0.05. There was no statistically significant difference (p ˂ .05) between the two groups that has not been detected clinically or radiographically. Clinical and radiographic success rates of garlic extract at 3 months were (80% and 72.7%), which declined at 6 and 12 months to be 76.4% 6 and 74.5% respectively. For NaOCl group, clinical and radiographic success rates were 87.3% and 85.5% at 3 months, 87.3% and 87.3% at 6 months and 89.1% and 87.3% at 12 months. A. sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.


| Study subjects
The total number of children enrolled in this investigation and applicable for specifications was 90 with 110 teeth. Their age ranged from 4 to 6 years.

| Randomization and allocation
Ninety eligible children have been randomly included in the study using computer generated block randomization list. Allocation was performed using properly sealed opaque envelope with treatment code and delivered by a resident in pediatric dentistry who completely ignorant of randomization code. The nature of irrigant solutions was masked for children and their parents/caregivers (i.e., single blinding).

| Pulpectomy procedures
One-stage pulpectomy was adopted in this study for treating primary molars without acute symptoms such as cellulitis or active discharge ELHEENY (Duggal, Nooh, & High, 2002). First, local anesthetic mepivicaine hydrochloride with levonordefrin 120,000 was administrated (ALEXANDERIA Co. for PHARMACUTICS, Egypt) and rubber dam application. Then, decay was removed, access to the pulp chamber and removal of the pulp chamber roof by # 558 non end cutting bur under air/water coolant. Coronal pulp tissue remnants were removed with sharp, sterile excavator, or large bur in a low speed handpiece. Kfiles used for instrumentation of manually up to a # 30 to 35 (Goerig & Camp, 1983). According to the irrigant solution, the children assigned with 1:1 allocation ratio into two parallel groups: group (1) "experimental group," 55 infected primary molars were treated with garlic extract, and group (2) "control group," 55 infected primary molars were treated conventionally with 2.5 ml of 2.5% NaOCl every time the file was changed.
Then teeth in both groups flushed with 5 ml of 17% ethylenediamine tetraacetic acid (EDTA; PREVESTDenPro®, India) for 30 s as a chelating agent used for the removal of the inorganic portion of the smear layer (Mello, Kammerer, Yoshimoto, Macedo, & Antoniazzi, 2010). Finally, the root canal was rinsed with 5 ml of saline, then obturated with ZOE (PREVESTDenPro®, India), which mixed to medium consistency and delivered using lentulo spirals (MANI Inc.) and restored with a suitable restoration (i.e., Amalgam restorations for one surface endodontically treated molars and stainless steel crowns for more than one surface involved; Ibricevic & Al-Jame, 2003). All cases recalled at 3, 6, and 12 months for clinical and radiographic evaluation.

| Clinical and radiographic assessment
The assessment was implemented by two pediatric dentistry specialists, and the nature of the treatment was masked for both. The primary outcomes were to evaluate the efficiency of garlic extract as an irrigant of infected primary molars clinically and radiographically.
The clinical criteria were scored according to the presence or absence of the following: (a) complain of pain, (b) swelling of gingiva, (c) fistulous tract, or (d) abnormal tooth mobility detected (Farooq, Coll, Kuwabara, & Shelton, 2000). The criteria of radiographic successes recorded at the base of existence of (a) root resorption, (b) persistent radiolucency at the furcation area up to 6 to 12 months after procedures, or (c) increase of the periapical and/or furcational radiolucency after treatment (Dentistry AAoP, 2009). Radiographic and clinical evaluation was scored independently. The presence of any negative sign, the tooth scored (0) and absence of all these abnormalities scored (1). The secondary outcomes were to detect the percent of different failure types accompanied by pulpectomy procedures after using garlic as an irrigant solution.

| A. sativum extract preparation
A 100 g of garlic cloves has been cleaned, peeled, and dried. Ethanol of 70% concentration was added for 60 s. The cloves were placed in a laminar air flow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated and extracted was diluted to the concentration of 25% with distilled water (Eswar, Venkateshbabu, Rajeswari, & Kandaswamy, 2013; Prabhakaran & Mariswamy, 2018).

| Statistical testing
Data were analyzed using the intention to treat analysis. Statistical analysis performed using the Qui-square test for binary variable. The level of significance was ˂0.05.

| RESULTS
Out of 137 patients, 90 children with 110 teeth were selected for the current study. Their age ranged from 4 to 6 years, with a mean (±SD) of 4.7 ± 7.1 years. The majority of children were females represented 61.8%. Also, pulpectomy procedures were indicated in mandibular primary molars (61.8%) more frequently than the maxillary ones (38.2%).
The mandibular second and first primary molars accounted for 33.6% and 28.2%, respectively, followed by the maxillary second primary molars (21.8%) and finally, the maxillary first primary molars (16.4%).
All demographic data were demonstrated in Table 1.
The interrater agreement for categorical items was measured using Cohen's kappa coefficient (κ = 0.94). This value indicated a strong agreement between the two examiners.  Figure 1). For the control group, the recorded radiographic success rates were 85.5% at 3 months and 87.3% at 6 and 12 months. A statistically significant difference between the two groups could not be clinically or radiographically detected throughout the follow-up period (p ˃ .05; Table 2).

| Clinical failure types
The common failures among children treated with garlic extract were tooth mobility accounted for 23.6%, followed by gingival swelling (20%), fistulous tract formation (18.2%), and finally, pain experience (12.7%). On the other side, tooth mobility recorded in 12.7% of infected molars treated with NaOCl, then gingival swelling and fistulous tract formation demonstrated 10.9%, and finally, 7.3% of the children complained of pain. In terms of the types of clinical failure, no statistically significant difference between the two groups (p ˃ .05; Table 3).

| Radiographic failure types
In regard to, persistent radiolucency, the increase in periapical and/furcational radiolucency and root resorption, there was no statistically significant difference between the two groups (p ˃ .05; Table 3).

| DISCUSSION
The integration between root canal mechanical cleaning and shaping, irrigation, and filling is essential for successful pulpectomy process   (Kandaswamy & Venkateshbabu, 2010). Up to the available data, the use A. sativum extract in endodontic treatment of primary teeth is limited especially the in vivo studies. Thus, the current study was conducted to compare garlic extract as an intracanal irrigant for pulpectomized primary molars with conventionally used NaOCl. Irrigation aimed to help in expel of pulp tissue, debris, and pathogenic microorganisms (Zehnder, 2006). NaOCl action is dual via (a) its oxidizing capability on microorganisms and (b) distortion of dentin collagen structure causing dissolution (Kandaswamy & Venkateshbabu, 2010).
The other arm of this study was garlic extract showed has antibacterial properties that have been proved against some microorganisms such as Pseudomonas, Klebsiella, Streptococcus mutans, and Porphyromonas gingivalis. Also, it was reported to be effective against E. faecalis similar to autoclave (Hugar et al., 2017). Garlic extract has better antibacterial properties when compared with calcium hydroxide (Eswar et al., 2013). The antibacterial characteristics of garlic attributed to one of its active components called thiosulfinates (e.g., Allicin; Ankri & Mirelman, 1999). The antimicrobial properties of allicin is chiefly attributed the total inhibition of RNA synthesis and partial inhibition of DNA and protein syntheses, suggesting that RNA is the primary target of allicin action (Feldberg et al., 1988). pulpectomy method (i.e., one versus two visits method). All of these variables have to be taken into consideration when comparing the current study results with other studies. However, it is useful to mention some of studies for comparison. The clinical result of the control group in the current study was 89.1% after 12 months, which slightly lower than the results of a study performed by Trairatvorakul and Chunlasikaiwan. They reported 96% and 93% clinical success rates at 6 and 12 months, respectively, out of 27 infected primary molars irrigated using 2.5% NaOCl. Although the radiographic success rate was 85% after 12 months of the follow-up period, which was comparable with this study results (Trairatvorakul & Chunlasikaiwan, 2008). Chen et al. (2017) reported 100% clinical and radiographic success rates at 6 and 12 months success rates of ZOE pulpectomy (Chen, Liu, & Zhong, 2017). These differences in findings might be related to the use of two visits pulpectomy method. Coll et al. (1985) used NaOCl in irrigation of 41 infected primary molars, and the success was 33 molars represented 80.5% in the first posttreatment revaluation in 6 to 36 months (mean 21 months), which considered to some extent comparable with the results of both groups in the current study (Coll, Josell, & Casper, 1985). The clinical and radiographic success varies from 85% 14 to 100% in a ZOE group of one-visit pulpectomy for 20 infected primary molars (Barcelos, Santos, Primo, Luiz, & Maia, 2011). This difference could be explained by the smaller the used sample size than that used in the present study. The findings of children of age 37 months or more revealed a 74.4% success for posterior teeth in a study performed by Coll and Sadrian (1996), and this is consistent with the current study results of the experimental group (Coll & Sadrian, 1996). Mortazavi and Mesbahi (2004) reported a 78.5% overall success rate of 52 necrotic primary teeth pulpectomized with ZOE (Mortazavi & Mesbahi, 2004). Mani et al. published an 83.3% clinical and radiographic success of ZOE pulpectomy when compared with calcium hydroxide pulpectomy in 60 cases (Ingle, 2008). Another study compared clinical and radiographic success rates of endoflas to ZOE using 3% NaOCl, the clinical success radiographic success after 12 months follow-up period were 89% and 63%, respectively (Pandranki et al., 2018).

| Types of clinical and radiographic failures
In the current study, abnormal tooth mobility was the dominantly observed clinical failures and periapical and/or furcational radiolucency after treatment. This is in agreement with Trairatvorakul and Chunlasikaiwan who reported 11% with pathological mobility and 22% of pulpectoized teeth revealed severe radiographic pathology (Trairatvorakul & Chunlasikaiwan, 2008). Also, the pathologic external root resorption and/or apical radiolucency were identified as the common radiographic failures in a study performed by Primosch, Ahmadi, Setzer, and Guelmann (2005).
The limitations of the current study were the strict specification criteria during subject selection stage and the relatively limited duration of the follow-up. Another restriction was the nature of treatment which could not be masked to the operator (single blinded study). However, the two specialists who performed clinical and radiographic assessments were blinded to the nature of treatment.
Another shortage of the current study is the relatively short period of follow-up. On the other hand, the current study owns some merits in terms of the following: (a) it is one of the in vivo randomized clinical trials which evaluate an herbal substance such as A. sativum extract as irrigant of infected root canals of primary molars, (b) the number of enrolled subjects was adequate, and finally, (c) this study may provide a reasonable scientific background for further researches in this era with more included subjects and longer follow-up interval.

| CONCLUSIONS
There is no statistically significant difference between A. sativum extract as an irrigant and sodium hypochlorite 12 months follow-up period. Garlic extract provides a good natural and potent antibacterial agent that can be used safely for irrigation of root canals of primary molars.