Assessment of endodontic treatment outcome by using single rotary file vs single reciprocating file with single cone obturation: A randomized clinical trial

Title- Assessment of****endodontic treatment outcome by using single rotary file vs single reciprocating file with single cone obturation a randomized clinical trial

**Null Hypothesis-**There isnodifferencein effectiveness on endodontic treatment outcome by using single rotary file vs single reciprocating file using single cone obturation

**Other****Hypothesis-**There is a differencein effectiveness on endodontic treatment outcome by using single rotary file vs single reciprocating file using single cone obturation

Primary****Objectives

1 To assess the preoperativemicrobialloadin single rotary file vs single reciprocating file

2 To assess the themicrobialloadpostoperativepainandapical healingin single rotary file and single reciprocating file postendodontic****treatment

Other****Objectives

1 To compare the apical healing and postoperative pain between single rotary file and single reciprocating file after the endodontic treatment

2 To compare the preoperative and postoperative microbial load between single rotary file and single reciprocating file

Methodology

IStudydesignA randomized clinical trial

II****Study population Teeth with apical periodontitis irreversible pulpitis in healthy cooperative patients aged 18 to 60 years

**X)**Method

Informed consent will be obtained from the patients after explaining the details of the study

Total sample size is 64 single rooted mandibular premolars with single canals

Preoperative radiographs of the selected teeth will be taken to ensure the inclusion criteria

After the application of rubber dam access cavity will be prepared maintaining the isolation and once the pulp tissue is extirpated 10 K file will be used to determine the working length using apex locator and later on it will be confirmed with a periapical radiograph

The initial sample pre instrumentation P1will be obtained by placing 10 size sterile absorbent paper point inside the selected canal for 1 minute and stored in sterile Eppendorf tube containing 1 ml of thioglycolate broth

Later the canal patency will be established Subsequently the canal will be prepared with different file systems according to the groups assigned

Based on computer generated randomization and sequentially numbered opaque sealed envelope method the teeth will be randomly assigned to two groups of n equals to 32 teeth each

**Group****A -**Trunatomy Dentsply rotary file system

Trunatomy files will be used in the following order orifice Modifier Glider and Prime File  as per manufacturers instruction.

**Group****B-**WaveOne gold Dentsply reciprocating file system

The canals will be instrumented using files as per the manufacturers instruction

Cleaning and shaping of the teeth will be carried out with the respective allotted file system using 17 percent  EDTA, 2.5 percent NaOCl and saline irrigation  Once the cleaning and shaping is completed calcium hydroxide dressing will be given and the teeth will be sealed with cotton and temporary restoration and the patient will be recalled after 7 days for obturation

Patients will be prescribed anti inflammatory as needed

After the 7 days duration the intracanal medicament dressing will be removed and the final sample post instrumentation P2 will be taken from the canals to compare and evaluate the microbial load

Once the sample is collected the procedure will be completed by irrigation with EDTA NaOCl and activated irrigation The canal will be then dried using paper points and obturated using bioceramic sealer with single cone obturation technique. The tooth will then be temporarily sealed

Post operative angled radiographs will be taken to check the quality of the endodontic treatment

Postoperative pain will be evaluated with VAS

Data on pain will be recorded by the patients at 4hr 8hr 12hr 24hr  and 48hr and 1week intervals

The patients will be instructed to take mild analgesics 400 mg of ibuprofen in case of pain Patients taking 400 mg of ibuprofen during the first 24 h in each group will be considered to have moderate pain at  4hr 8hr 12hr intervals

Patients taking more than 400 mg of ibuprofen during the first 24 hr and those taking any dose of the medicine after 24 hr will be excluded from the study

Post operative evaluation of the apical healing will be checked after 6 months by taking radiographs and the periapical index PAI scoring system by  Orstavik et al 1986 with its 5 point radiographic reference scale to score the absence presence and increasing severity of periapical disease