Comparative Evaluation of Clinical and Radiographic Success of Aloe-Vera and Formocresol Pulpotomy in Primary Molars- A Randomised Control Trial

Introduction

Pulpotomy is the procedure of complete removal of the coronal part of the pulp and then placing a medication or dressing that helps in healing and maintains tooth vitality.¹ Formocresol (FC) over the years has still remained the benchmark.² Despite it’s better success rate there is a shift from usage. FC is a pulpal irritant and it produces devitalization of root pulp. It has antigenic, mutagenic and carcinogenic properties.² There is longstanding debate on the use of Formocresol due to systemic toxicity and devitalization of root pulp. The goal of pulpotomy is to retain pulp vitality; hence the search for an ideal pulpotomy agent is ongoing. In this regard, many newer materials have been formulated and studied over the years.³

Aloe (Aloe vera) is an important and traditional medicinal plant belonging to the family Liliaceae. Aloe vera has its uses in various systemic conditions like skin and bowel disorders, diabetes and hyper-lipidemia. It has also been used in dentistry for its beneficial properties such as biocompatibility, anti-inflammatory, antimicrobial, wound healing, and secondary dentin formation.^4,5

Composition and mechanism of action of Aloe vera:

It is made of 99% water and remaining 1% has active ingredients which include polysaccharides, essential oils, lipids, amino acids, minerals, enzymes, and glycoproteins.⁵ Acemannan, a polysaccharide present in aloe vera is biocompatible and can bring about secondary dentin formation.⁴ Carboxy peptidase’s present in Aloe vera inactivates bradykininn, a principal mediator of inflammation.⁵ Magnesium lactate inhibits histidine decarboxylase, thereby preventing the formation of histamine from histidine in mast cells (Klein AD-1980).⁶ In addition Aloe vera has shown antimicrobial, wound healing and moisturizing properties.⁷ Therefore, it is used in several conditions including aphthous ulcers, burning mouth syndrome, prevention of dry socket, direct pulp capping, pulpotomy, pulpectomy and periodontal disorders.^4,5,7,8

Cytotoxicity of Aloe-vera: Sehgal I et al. have reported that purified (decolorized) whole leaf Aloe vera and inner leaf Aloe vera as non-cytotoxic, non-genotoxic in histidine reversion and DNA repair assays. Whereas Aloevera juice made of unpurified (non-decolorized) whole leaf which contains Aloin- a latex. This, on long term oral administration (>3 months) in rats has caused mucosal hyperplasia of the large intestine.⁹ In the present study we have used purified and certified Aloe vera preparation which is preservative free inner fillet, Lily of the desert, IASC and USDA certified as organic from USA (Figure-1) as topical medicament for pulpotomy treatment. There are no comparative studies between Aloe vera pulpotomy and Formocresol pulpotomy in deciduous teeth. Hence, the present clinical research was undertaken to assess and differentiate the clinical and radiological success rates of Aloe vera and Formocresol pulpotomy in deciduous molars.

Materials and methods

Ethical approval was taken from the institutional ethical committee and informed parental consent was obtained.

Sample population characteristics: The sample consisted of 34 children (16 boys and 18 girls) visiting the department of pediatric dentistry in Bengaluru for dental treatment between 2017 to 2019

• Children with deep carious lesions in primary molars and indicated for pulpotomy.

• Children aged between 4 to 8 years including both boys and girls.

• Healthy children with cooperative behavior

Demographic data are given in Table-1. The subjects were selected based on the following inclusion and exclusion criteria. Inclusion criteria^3,5

1. Primary molars having deep cavities and caries excavation caused exposure of pulp.¹

2. Haemorrhage from the amputation site should be pale red and easy to control.

3. Pain if present should neither be spontaneous nor persistent.

4. Tooth should be vital with healthy periodontium.

5. Tooth should be restorable.

6. Tooth should possess at least 2/3rds of its root length.

Exclusion criteria^3,5

1. Caries penetrating floor of the pulp chamber.

2. Post amputation unsuccessful hemorrhage control.

3. Radiographic evidence of pulp stones, internal/ external resorption, furcation/ periapical pathology.

Sample size calculation: Determination of sample size was done using G* power version 3.0.10. Sample size required to achieve the power of 80% (β =0.2) and type1 error at 5% (α = 0.05) was 60. Considering subject attrition, the sample size was increased to 70.

The two study groups based on the pulpotomy agent used and the mechanism of action were,

Group I (Experimental group): Aloe vera medicament acts by preservation of radicular pulp tissue by its biocompatibility, anti-inmflammatory, antimicrobial, wound healing property.

Group II (Control group): Dilute formocresol medicament acts by devitalization of radicular pulp tissue by coagulative necrosis.

The patients were then randomly allocated their group with 30 in each group as shown in Table-1 (sample distribution). Local anesthesia was administered and the molar was isolated using a rubber dam. Caries excavation was carried out by a sterile spoon excavator followed by deroofing the pulp chamber with a highspeed #330 bur. Amputation of the pulp was done using a sterile and sharp spoon excavator. The bleeding was controlled using a cotton pellet moistened with saline. Hemostasis was achieved within five minutes. If hemorrhage continued, the patient was excluded from the intended research and appropriate treatment given. Pulp medicaments were applied as follows:

• Group I (Aloe vera): A sterile cotton pellet moistened with Aloe-vera (Fig-1a) (Preservative free inner fillet, Lily of the desert, IASC and USDA Certified Organic, USA) was placed on the amputated pulpal surface for five minutes and then removed, followed by covering pulp stumps with zinc oxide eugenol (ZOE), on which intermediate restorative material (IRM) was placed.

• Group II (Formocresol): A sterile cotton pellet moistened with Formocresol (diluted at 1:5) (Fig-1b) was placed on the amputated pulpal surface for five minutes and then discarded, followed by covering the pulp stumps with ZOE, IRM was placed. Final restorations were performed with stainless steel crowns (SSCs). Two blinded examiners calibrated for inter and intra examiner variations (kappa value- 0.9) assessed the patients clinically and radiographically (fig-3a, b, c, d) for the success or failure of pulpotomy based on the following criteria at 1-month, 3-months, 6-months follow-up visits.³

Post-operative evaluation criteria for clinical and radiological features³

A. Clinical evaluation criteria

• Presence of pain

• Tenderness to percussion

• Intra or extra-oral swelling

• Intra or extra-oral sinus opening

• Pathologic mobility

B. Radiographic evaluation criterias³

• Periodontal ligament space widening

• Inter-radicular/ periapical radiolucency

• Internal or external root resorption

Statistical Analysis: The results were analyzed using descriptive statistics and comparing the two treatment groups with respect to demographics, clinical and radiographic parameters. Kappa statistics were used to measure inter and intra-examiner agreements for dichotomous observations. Percentages were used to categorize and summarize data. Proportions were compared using chi-square test. Statistical significance was set at a p-value=0.05.

Results

Table-1 shows demographic data on distribution of subjects and teeth in the two groups.

Table-2 shows clinical criteria of evaluation i.e., pain, mobility, sinus/fistula and pathological mobility which were absent in both groups by the end of 1, 3 and 6 month follow up visits. This shows 100% clinical success of pulpotomy procedures in two groups.

Table-3 shows that at baseline and one-month follow up, no significant radiographic changes were noticed in both groups. At three months recall, furcation radiolucency was seen in one group I and three teeth in group II along with pathologic internal resorption in one in group II. At 6-months follow up furcation radiolucency was noticed in two teeth in group I and three teeth in group II along with pathologic internal resorption in one tooth in group II.

All the clinical parameters i.e., pain, mobility, sinus/ fistula and pathological mobility were absent showing 100% success in both Aloe vera and Formocresol groups at 1, 3 and 6 months respectively (Table -2). Radiographic assessment after 3-months showed 86.6% success rate in the Formocresol group and was lower than Aloe-vera group which had a success rate of 96.6%. This difference was not significant (P=0.16). At the 6-month follow up, the success rate was again higher the in Aloe vera group (93%) compared to the Formocresol group (86.6%). These differences were statistically nonsignificant (P=0.38).

Discussion

Pulpal inflammation spreads faster in primary teeth as the pulp reacts less favorably and degenerates more easily here. The higher potential for repair is due to its rich vascularity and more cells.¹⁰ Pulpal inflammation in primary teeth can be treated successfully with pulpotomy. The ideal pulpotomy agent should retain the root pulp vitality. Such an ideal agent does not exist yet. Formocresol has toxic, mutagenic and carcinogenic properties. However, all new pulpal agents are compared with this gold standard, Formocresol. Still there is a quest for alternative pulp medicaments and techniques.¹¹

In traditional medicine, Aloe vera is used for its cosmetic and anti-inflammatory properties. The mucilaginous gel obtained from the leaf has been used in the treatment of gout, arthritis, dermatitis, acne, peptic ulcers, and burns (Ganginella and Cappasso-1997).⁵ In minimally intervasive dentistry Aloe-vera extracts are used as potential natural antiseptic agents.¹² A study conducted to evaluate pulpotomy with Acemannan and compared with Formocresol has shown that it has advantages over it.¹³ Acemannan did not produce any inflammation or necrosis of pulp tissue instead, it helped in the formation of a partial hard tissue barrier after pulpotomy. Hence, Acemannan sponge can be used as an effective pulpotomy agent, and it offers a valuable alternative biodegradable material for vital pulp therapy in human primary teeth.¹³

Gupta N et al. assessed the pulp healing potential of Aloe vera. In this study, 15 primary molars were subjected to a pulpotomy procedure using Aloe vera and were clinically evaluated one month later.⁵ All these patients were free from pain, abscess, mobility, and sinus tract. Histopathological examination after the extraction of these teeth two months later showed all the signs of healing. Similar results were seen along with the formation of dentinal bridge and soft tissue organization of the pulp in the Acemannan-treated group.⁴

Sahawat D et al. showed a significant increase in endothelial growth factor levels, osteopontin, and expression of type-I collagen.¹⁴ This suggests it as a possible therapeutic medicament for regeneration of cementum. These results were consistent with the findings of Jittapiromsak N et al. ¹⁵ They found that Acemannan increases pulp cell proliferation and enhances pulp tissue organization with mild or no inflammation. It has the capacity to promote the differentiation of immature dendritic cells.¹⁶ Boonyagul S et al. conducted an animal study that showed that the pulp tissue appears as normal soft tissue. Similar results were shown by Songsiripradubboon S. et al. ⁴ Acemannan accelerated new cementum, periodontal ligament and alveolar bone formation in class-II furcation defects. This suggests that Acemannan can be a biomolecule for periodontal tissue regeneration.¹⁸

In this research, a single operator performed tooth assignment and pulpotomy procedures. Two independent observers who were blinded for the study groups assessed clinically and radio-logically at baseline, 1 month, 3 month, and 6 month follow up visits. All the clinical parameters i.e pain, mobility, sinus/fistula and pathological mobility were absent showing 100% success in both Aloe-vera and formocresol groups at 1 month, 3 month and 6 months respectively (Table -2). The clinical findings seen in this research were in accordance with a study carried out by Gupta G et al, they observed 100% clinical success at 6 month follow up. ⁵

Radiographic assessment after 3-months showed 86.6% success rate in the Formocresol group and it was lower than the Aloe vera group 96.6%. At 6-month followup, the success rate was again higher in the Aloe vera group (93%) compared to Formocresol group (86.6%). Although, the differences were statistically nonsignificant. Furcal radiolucency was seen in 10% of the Formocresol group and 6% of the Aloe vera group. Root resorption was seen in 3% of Formocresol cases. The radiographic failures in pulpotomy can be due to the clinical errors in case selection and diagnosis. Another reason can be due to the release of free eugenol from ZOE sub base. The present research findings are in accordance with Shivayogi MH et al, Kritika G et al, Pawan J et al and Esma Y et al. ^5,19,20,21 The higher success rates in Aloe-vera pulpotomy in the present research could be attributed to its anti-bacterial, antiinflammatory, antiviral, antifungal, moisturizing and pain relief properties. Aloe-vera is effective in controlling haemorrhage, antisepsis and sterilization apart from maintaining vitality in radicular pulp. Stainless steel crowns were placed on all the treated teeth as suggested by Randall RC and this prevents leakage of the final restoration thereby giving a better result.

Contradictory evidence: Furcal radiolucency was seen in 10% of the Formocresol group and 6% of the Aloe vera group.

Limitations of the study: In this study clinical and radiological follow ups were done only for a short duration of six months. Histological evaluation of the pulpal response to the medicaments was not carried out.

Unanswered questions: The reasons for radiographic failures. These can be due to the clinical errors in case selection and diagnosis. Another reason can be due to the release of free eugenol from ZOE sub base which is in direct contact with pulp.

Newer questions raised: Pulpotomy success rate with long-term follow-ups. Further studies can be undertaken with a larger sample size and witlong-term follow-upup. Histological evaluation of the pulpal response to Aloevera pulpotomy can be assessed after extracting the pulpotomized teeth.

Conclusions

Clinical and radiological success rates were higher in the Aloe vera group compared to the Formocresol group in primary molars. Hence, Aloe vera can be used safely in primary teeth as it is an herbal medicament and has no adverse effects.

Financial support and sponsorship

Nil

Conflict of interest

Nil