Clinical Trials Logo

Clinical Trial Summary

The aim of this prospective in vivo randomized clinical trial to evaluate influence of combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2% (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste, Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted necrotic teeth.

According to the inclusion criteria the patients enrolled in the study and allocated randomly into three groups either combination of calcium hydroxide paste intracanal medication with 2% chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B) or mechanical preparation without intracanal medications (group C) the endodontic treatment is done at two visits.

The samples of endotoxin divided into three groups: after access (S1), after mechanical instrumentations (S2), after removal intracanal medication (S3), all samples taken by a sterile paper points introduced in the root canal for the working length for 60 seconds.

firstly the patient's medical and dental history is taken. the patients assign on informed consent. and then anaesthetized and access cavity performed and root canal preparation is done by Revo-s system then irrigation and intracanal medication placement inside to canal. the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2 weeks after first visit. the operator will recall the patient to check the records

second visit After 2 weeks from application of ICM, rubber dam will be applied then removal of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals after irrigation and removal of the remnants of the intracanal medicament with the saline solution.

- Removal of the paper sample to determine the endotoxin concentration.

- The canals will be obturated by single cone technique using gutta percha point tapered 0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final apical size of the file and the root canal sealer will be resin sealer (Adseal, META BIOMED CO., LTD, Korea).

- Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first visit (at the day of the Obturation) before the beginning of Obturation.


Clinical Trial Description

Medical and dental history: diagnostic charts will be collected in a case report from by the investigators and confirmed for eligibility with the assistant supervisor.

Radiographic examination: preoperative radiographs will be taken to examine the tooth structure, caries detection, periapical status.

Clinical examination: intraoral examination include visual examination for caries, restorations, swelling, fistula, mobility, percussion were done.

Diagnostic criteria for necrotic tooth:

1. The patient marks moderate to severe pain on the numerical rating scale (NRS)a horizontal line of 11 marks and 10 intervals each takes number form 0 - 10 0 reading represents "no pain", 1- 3 readings represent "mild pain", 4- 6 readings represent "moderate pain", 7- 10 readings represent "severe pain".

(recording baseline degree of pain preoperatively before initiating the endodontic treatment ) All step will done by operator.

The measurement time will be at 4 hours, 24 hours, and 48 hours and after 14 days. (Day of Obturation)

2. The patient not responding to electric pulp tester at higher level than the contralateral tooth or the adjacent tooth if the contralateral one is missing.

3. Preoperative periapical x- ray film is done to detect any periapical changes.

Intervention:

Forty five patients will include were allocated by random or by chance to receive several clinical interventions and one of these interventions was control (Group A) where the patients did not receive any intracanal medication, (Group B) where the patients receive intracanal medication calcium hydroxide (CALCIPAST Paste, (Poland) and chlorhexidine 2 % gel. (Gluco-Chex 2%, Cerkamed, Poland), (Group C) calcium hydroxide paste only CALCIPAST Paste (Poland).

Procedure steps:

At the 1st appointment.

- Each patient will be given a numerical pain rating scale chart in order to rate his /her presenting pain as preoperative pain

- Anesthesia will be done with Carpule 3M™ ESPE™ Ubistesin™ Articaine HCI 4% & Adrenaline 1:100,000 3M Australia the tooth with decayed using a standard dental aspirating syringe.

- After diagnosis disinfecting the tooth surface by 30% H2O2 (Perfect Medical, Egypt) followed by 2.5% NaOCl inactivated with sodium thiosulfate (El Nasr CO. for pharmaceuticals and chemicals).

- Access cavity will do under rubber dam isolation and with Sterile burs for access cavity preparation with distilled water as a coolant and flaring will done by endo-z bur.

- If successful anesthesia occurs, working length will be determined with an apex locator (Root ZX, J.Morita, Irvine, California, USA.) then confirmed with intraoral periapical radiograph (Kodac Dental film, speed D, size 2, Carestream Health, Rochester, NY, USA) to confirm the length to be 0.5-1 mm shorter than radiographic apex.

- The first sample of endotoxin (S1) is taken by a sterile paper points after access cavity preparation and introduced in the root canal for the working length for 60 seconds.

- The sample is then placed in a pyrogenic free plastic tube and frozen to negative 200c for endotoxin determination by LAL test.

- Canal instrumentation will be done using NiTi rotary files system (Revo-S MicroMega, France) in an endodontic motor (X-Smart, Dentsply Maillefer, USA.) according to the manufacturer instructions to ensure adequate space for placement of the intracanal medicaments and proper removal of bacteria and debris, till size AS 35 file. The rotary files will be introduced inside the canal with EDTA gel (MD-Chelcream, META BIOMED CO., LTD, Korea) as lubricant.

- The irrigant solution will be NaOCl with concentration 2.5% for its tissue dissolving properties between each file and will be delivered by disposable plastic syringe.

- Another sample (S2) will be taken after the cleaning and shaping and before placing the intracanal medications by sterile paper point for endotoxin determination.

- The first group will be subjected to combined therapy of both calcium hydroxide intracanal medication CALCIPAST Paste (Poland), with 2% chlorhexidine gel intracanal medication (Gluco-Chex 2%, Cerkamed, Poland) after the cleaning and shaping for 2 weeks period.

- The second group will be subjected to calcium hydroxide intracanal medication alone for 2 weeks period after the cleaning and shaping. Calcium hydroxide will be in form of ready-made paste in a measured special syringe CALCIPAST (Poland).

- The third group will receive plain cotton with temporary filling without any intracanal medication.

- Placement of the intracanal medications by lentuolo spiral by low speed hand piece and condensed with paper points.

- Temporary filling is done by glass ionmer filling to ensure proper sealing with no leakage of any oral fluids inside the root canal, which may disturb the action of the intracanal medication.

- Pain will be assessed by numerical pain rating scale (NRS) will be given to each patient to complete a t home at the specified times at 4, 24, 48 hours after the first visit.

At the 2nd appointment:

- After 2 weeks from application of ICM, rubber dam will be applied then removal of the temporary dressing by following the previous infection control protocol, then a sterile paper point (S3) will be introduced into the canals after irrigation and removal of the remnants of the intracanal medicament with the saline solution.

- Removal of the paper sample to determine the endotoxin concentration.

- The canals will be obturated by single cone technique using gutta percha point tapered 0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final apical size of the file and the root canal sealer will be resin sealer (Adseal, META BIOMED CO., LTD, Korea).

- Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first visit (at the day of the Obturation) before the beginning of Obturation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03009006
Study type Interventional
Source Cairo University
Contact Mohammed Saadi Alarbeed, master degree candidate
Phone +201023455553
Email mohammed-saadi@dentistry.cu.edu.eg
Status Not yet recruiting
Phase N/A
Start date January 3, 2017
Completion date January 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04035330 - Effect of Etidronate in Sodium Hypochlorite Versus Sodium Hypochlorite on the Intensity of Postoperative Pain N/A
Not yet recruiting NCT05522270 - Concentrated Growth Factor Versus Platelet Rich Fibrin in Revitalization of Necrotic Young Permanent Incisors N/A
Completed NCT04606719 - Healing Potentiality Of Blood Clot S-PRF and A-PRF in the Treatment Of Necrotic Mature Single-Rooted Teeth With Chronic Peri-Apical Periodontitis N/A
Not yet recruiting NCT05988788 - Effect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth N/A
Completed NCT04983524 - Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp N/A
Not yet recruiting NCT06116214 - Effect of Vachellia Nilotica Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Load Reduction in Mandibular Premolar Teeth With Necrotic Pulp Phase 4
Not yet recruiting NCT03698188 - Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates N/A
Not yet recruiting NCT05289843 - Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants N/A
Not yet recruiting NCT06310044 - Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth N/A
Not yet recruiting NCT03059290 - Incidence of Post-Operative Pain After Single Visit Root Canal Treatment in Necrotic Teeth Using Two Different Rotary Systems (Protaper Nex t& Neolix File) N/A
Completed NCT03084601 - Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy Phase 4
Completed NCT04646538 - Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography Early Phase 1
Completed NCT03708081 - Comparative Evaluation of Different File Systems in Postoperative Pain
Not yet recruiting NCT05419752 - Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling Phase 2/Phase 3
Completed NCT05775081 - Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth N/A
Not yet recruiting NCT05620147 - Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp N/A
Not yet recruiting NCT05146713 - Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars Phase 2/Phase 3
Not yet recruiting NCT04035070 - Effect of Irrigation With Antibiotic-containing Solutions on Postoperative Pain and Intra-canal Bacteria Phase 4
Not yet recruiting NCT04728386 - Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin or Sodium Hypochlorite N/A
Not yet recruiting NCT03301259 - Postoperative Pain Following Treatment of Asymptomatic Necrotic Mandibular Molars in Single Visit Using Wave-one Reciprocating Instruments Versus One-Shape Rotary Instruments N/A