A problem commonly faced in pediatric clinics is the restoration of primary maxillary incisors severely destroyed by trauma or caries.

Most cases are observed among children with early childhood caries that result in early involvement of the pulp especially in maxillary incisors.

Premature loss of carious primary incisors may affect the speech , decreased masticatory efficiency, leads to psychological problems if esthetics are compromised. this issue may lead to a negative impact on the quality of life of the child.

Pulp involvement of primary teeth in the caries susceptible children occurs relatively frequent. This is due to the small size of the teeth, relatively large pulp chambers, rapid caries, progression and sometimes failure to diagnose and treat caries early and appropriately.

Pulp therapy in deciduous teeth is a complex treatment due to the instrumentation procedures, the complexity of the apical delta, the biological cycle of the deciduous teeth ,physiological root resorption, and rhizolysis and long treatment sessions during which the child sometimes does not always cooperate.

UK National Clinical Guidelines in Paediatric Dentistry,(2006) describes different pulp therapy for primary teeth vary from indirect pulp capping , Desensitising pulp therapy, pulpotomy, pulpectomy or even tooth removal

American Academy of Pediatric Dentistry (AAPD) 2009 defines pulpectomy as a procedure which involves removal of the roof of pulp chamber in order to gain access to the root canals which are debrided, enlarged, disinfected and filled later with a resorbable material.

The primary objectives of cleaning and shaping the root canal system are removing soft and hard tissue containing bacteria, providing a path for irrigants to the apical third, supplying space for medicaments and subsequent obturation, retaining the integrity of radicular structure.

An ideal root canal filling material for deciduous teeth must have several properties: Harmless to the periapical tissues and permanent teeth germs. Resorbing readily if pressed beyond the apex. Antiseptic, biologically safe, cost effective,easy to manipulate, easily removed If necessary. Resorbable(at the same rate as the primary root), radiopaque. Adhesive to root canal walls, non shrinking, non soluble.

Various material have been used as endodontic obturating agents in primary teeth.among the most common are: zinc oxide eugenol (ZOE),used either alone or applied with formocresol, iodoform and camphorated parachlorophenol pastes as well as iodoform and calcium hydroxide mixtures

Since 1930s Zinc Oxide Eugenol has been the material of choice, but it has certain disadvantages : Slow resorption Possibility of irritation to periapical tissues, necrosis of bone and cementum and it may alters the path of eruption of succedaneous tooth. Cause deflection of the succedaneous tooth reported anterior cross-bite, palatal eruption, and ectopic eruption of the succedaneous tooth Have an adverse effect on resin-based products cured in contact with them.

Mixing Calcium Hydroxide with other substances to improve properties such as antibacterial action, radiopacity, flow and consistency. Recently there have been reports that a mixture of Calcium Hydroxide, Zinc Oxide Eugenol and Iodoform have good antimicrobial, and resorptive capabilities and can be used as an alternative to the traditional Zinc Oxide Eugenol.

Other root canal obturating materials " iodoform pastes , calcium hydroxide combination pastes and antibiotic pastes ", are now available . They were evaluated in a few studies requiring more detailed observation in term of the antibacterial action , biodegradability as well as clinical and radiographic evaluation

The aim of this study was two folded: 1-In vivo : A-Clinical and radiographic evaluation of calcium hydroxide based material Apexcal , zinc oxide eugenol with iodoform Zical compared to zinc oxide eugenol as root canal obturating materials for primary teeth. B-To assess anti microbial effect of the three investigated materials 2-In vitro : To determine their biodegradability

I . In vivo study

The subjects included in this study was 80 children selected from those attending the outpatient clinic, Pediatric Dentistry Department , Faculty of Dentistry, Minia University . Their age ranged from 3 to 5 years , each patient had at least 2 carious maxillary primary incisors with irreversible pulpitis requiring root canal treatment

Patients were randomly assigned into two groups according to the obturating material used :

Group I: Apexcal group Group II: Zical group

For both experimental groups one incisor at least was obturated using "Apexcal" for group I or "Zical" for group II and the other incisor was obturated using the ZOE.

Criteria for selection

According to UK National Clinical Guidelines in Pediatric Dentistry (2006)

Clinical criteria: Patient and parents cooperation Absence of any systemic condition Tooth diagnosed as having irreversible pulpitis History of unprovoked pain Tooth is restorable Absence of tooth mobility No tenderness under percussion

Criteria for selection

According to UK National Clinical Guidelines in Pediatric Dentistry (2006)

Radiographic criteria: No widening of periodontal membrane space No evidence of internal or external root resorption No evidence of calcified degeneration in the pulp No periapical radiolucency physiological root resorption if present was not more than 1/3 of the root

Materials

Methods
Pulpectomy was undertaken by the same operator in one visit as follow: Pre-operative periapical radiograph Local anaesthetic. Disinfection. Isolation The decayed tooth structure was removed; access to the pulp chamber Amputation of the coronal pulp tissue

Working lengths of root canal was estimated , keeping 2 mm short of the radiographic apex Small file was inserted into the canal and filing canal walls lightly and gently. Irrigation. drying the canal with pre-measured paper points Obturating.

The access cavity was filled with reinforced zinc oxide eugenol , the tooth was restored with esthetic restoration Immediate post operative radiograph was taken thereafter in order to identify the quality and the extent of filling. All children were followed for a period of one year to evaluate treatment outcomes both clinically and radiographicaly.

Evaluation Criteria
(AAPD 2009) Clinical evaluation: History of pain Loss of clinical crown/ coronal restoration , recurrent caries Sensitivity to percussion Signs of erythema or swelling in the surrounding gingival tissue and mucosa Presence of fistula / sinus in the surrounding gingival tissue and mucosa.

Radiographic evaluation: Radiographic evaluation was carried at 0, 1, 3, 6 and 12 months intervals, evaluation criteria included: Presence or absence of periapical radiolucency Presence or absence of pathological internal or external root resorption Presence or absence of widening of periodontal membrane space

Evaluation of Anti microbial effect of selected material

a- Sample collection and transportation

b- Serial dilution

c-Cultures incubated aerobically at 37 Co for 24 hours

d- Comparing bacterial count before (left) and after (right) application of each selected material

II .Invitro Study
Biodegradability of selected materials

1-Teflon mold of known internal diameter and weight

2- Mold cleaning with acetone in ultra sound bath

3- Filling the mold followed by backing

4- Samples storage for 50% longer than setting time at 37C and 100% relative humidity

Preparation of a sample for biodegradability measurement

1- Samples immersion in SBF for 24 hours at 37C

2- Sample was rinsed with distilled water which was collected in Petri dish

3- The collected solution was evaporated; the residues were dried in oven 105C for 30 minutes

4- Weigh the Petri dish after cooling

Steps of biodegradability measurement of the selected material

I. In vivo study

Results of clinical evaluation

Pain
Pain Pain
Recurrent caries

Sensitivity to percussion Fistula formation Fistula formation

Fistula formation

Sensitivity percussion Sensitivity toto percussion

Loss crown Loss ofof crown Gingival erythema Gingival erythema

Loss of crown

Recurrent caries Recurrent caries

Gingival erythema

of free Percentage free of cases Percentage of free Percentage cases cases

100% 100% 100% 80% 80% 80%

60% 60%
40% 40% 20% 20%
20% 40%

60%

Figure 8:Clinical evaluation of cases treated with zinc oxide eugenol Figure 6:Clinical evaluation of cases treated with Apexcal

Figure 7:Clinical evaluation of cases treated with Zical

1st 3rd 6th 12th 1st 6th 12th Follow3rd uo period (months) Follow uo uo period period (months) (months) Follow

1st

3rd

6th

12th

2- Results of radiographic evaluation

100% 100% 100%
free offree Percentage cases of free Percentage of Percentage cases cases
PDL widening PDL widening PDL widening periapical periapical radioloucency periapical radioloucency radioloucency Internal root Internal root resorption Internal root resorption resorption External root External root External root resorption resorption resorption

80% 80% 80% 60% 60% 60% 40% 40% 40% 20% 20% 20% 0% 0% 0% 1st 1st 3rd3rd 3rd 6th 6th 12th 12th 6th 12th Follow up period (months) Follow up period (months) Follow up period (months)

Figure 11:Radiographic Radiographic evaluation evaluation of teeth treated with Figure teeth treated with Figure9: 10: Radiographic evaluation of teeth treated with zinc oxide eugenol Apexcal Zical

3-Results of antimicrobial effect

99.50%

Percentage of reduction

99.40% 99.30% 99.20% 99.10% 99.00% Tested material

Apexcal Zical ZOE

Figure12:Percentage of reduction in CFU\ml after 7 days of application of tested materials

II .In vitro Study Biodegradability test

Percentage of wieght loss

0.81% 0.80% 0.79% 0.78% 0.77% 0.76% 0.75% Tested material Apexcal Zical ZOE

Figure 13:Biodegradability after 24 hours immersion period

A-Preoperative radiograph

B-Immediate postoperative

C-1st month

D-3rd month E-6th month F-12th month

Photo radiograph of 4 years old female where upper right central incisor was filled with zinc oxide eugenol while upper left incisor was filled with Apexcal

A-Preoperative

B-Immediate

C-1st month

D-3rd month

E-6th month

F-12th month

Photo radiograph for 3 years old male where upper right central incisor was filled with Zical while upper left incisor filled with zinc oxide eugenol

A-Preoperative radiograph

B-Immediate postoperative

C-1st month

D-3rd month

E-6th month

F-12th month

Photo radiograph for 3 and half years old male where upper right central incisor was filled with zinc oxide eugenol while upper left incisor filled with Apexcal

A-Preoperative radiograph

B-Immediate postoperative

C-1st month

D-3rd month

E-6th month

F-12th month

Photo radiograph for 4 years old male where upper right central incisor was filled with zinc oxide eugenol while upper left incisor filled with Apexcal

Apexcal and Zical had clinical and radiographic success rate compared to zinc oxide and eugenol as a root canal filling material in primary anterior teeth.
Apexcal and Zical had antibacterial efficacy as well as zinc oxide eugenol Apexcal , Zical and zinc oxide eugenol are considered to be of low solubility in body fluids thus they could be used as root canal filling material without any adverse effect .

Apexcal and Zical could be a suitable alternative to zinc oxide eugenol as root canal filling material for primary anterior teeth. Studies with larger sample size and larger evaluation period are required to assure clinical and radiographic success and clarify any possible adverse effect . Further studies are required to investigate the efficacy of Apexcal and Zical as root canal filling material for non vital primary teeth. Further researchs should be carried out to evaluate other properties of selected root canal filling material including dimensional changes , flow and adhesion to root canal .