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Necrotic PulpNCT03009006

Post Operative Pain and Level of Endotoxins With Calcium Hydroxide and Calcium Hydroxide Mixed With Chlorhexidine in Treating Necrotic Teeth

A study testing Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting and Calcium Hydroxide Paste - Non-Setting in people with Necrotic Pulp, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Necrotic Pulp
What is being tested?
Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting and Calcium Hydroxide Paste - Non-Setting
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
No sites listed yet
Study dates
3 Jan 2017to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients in Good Health(American Society Of Anaesthesiology Class II or higher).
  • Adult patients from both genders older than 18-50 years old suffering from chronic periapical periodontitis with necrotic pulp.
  • single rooted teeth (maxillary and mandibular).
  • Patients who can understand numerical rating scale (NRS)
  • Patients able to sign informed consent

Who cannot join

  • Patients with Vital tooth.
  • Patients having active pain in more than one tooth.
  • Patients who had taken analgesics in 12 hours preceding the preparation.
  • Any type of teeth with multi roots.
  • Pulp hyperemia or any other conditions other than pulp necrosis like pulpitis or previously accessed teeth with temporary fillings and patients suffering from chronic disease (systemic diseases).
  • Pregnant or mentally retarded patients.

Trial locations and contacts

No sites are listed yet.

Mohammed Saadi Alarbeed, master degree candidate contact

+201023455553

mohammed-saadi@dentistry.cu.edu.eg

Geraldine M. Ahmed, ass. professor contact

+201226322227

geraldine.ahmed@dentistry.cu.edu.eg

About this study

Official title: Effect Of Combination of Calcium Hydroxide And Chlorhexidine Gel 2% as Intracanal Medication in Comparison to Calcium Hydroxide Paste as Intracanal Medication on Postoperative Pain And Bacterial Endotoxins in Necrotic Teeth:

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.

Read more

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.
Read the detailed 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.
Conditions
Necrotic Pulp
Being tested
Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting, Calcium Hydroxide Paste - Non-Setting
Keywords
Calcium hydroxide intracanal medication, Ca(OH)2 intracanal medication, Chlorhexidene gel, CHX gel, Root canal treatment
Medical subject headings
Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-SettingDrug

    Also called CHX gel, Ca(OH)2 paste

    Calcium Hydroxide Mixed With Chlorhexidin efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria

  • Calcium Hydroxide Paste - Non-SettingDrug

    Also called Ca(OH)2 intracanal medication

    Calcium Hydroxide The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage

Study groups in NCT03009006
Study groupRoleWhat they receive
Calcium Hydroxide Mixed With ChlorhexidinExperimentalefficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria.
Receives: Drug: Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting
Calcium HydroxideExperimentalThe antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage
Receives: Drug: Calcium Hydroxide Paste - Non-Setting
PlaceboPlacebo comparatorMechanical preparation without intracanal medications.
Receives: Drug: Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting; Drug: Calcium Hydroxide Paste - Non-Setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative pain

    intensity of postoperative pain between visits by numerical Rating Scale (0- 10)

    Measured: 4, 24, 48 hrs and 2 weeks after completion of treatment

Secondary outcomes (1)
  1. bacterial endotoxins reductions

    bacterial endotoxins reduction will be assessed by ELISA technique.

    Measured: After access cavity, after mechanical preparation and after removal of intracanal medication (2 weeks after the first visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study start3 Jan 2017
  3. Primary completionOct 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009006
Sponsor's protocol ID
CEBC-CU-2016-10-147
Status last verified
Jul 2017
First submitted
30 Dec 2016
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Singh, Ripu Daman, et al.

  • Walton RE, Holton IF Jr, Michelich R. Calcium hydroxide as an intracanal medication: effect on posttreatment pain. J Endod. 2003 Oct;29(10):627-9. doi: 10.1097/00004770-200310000-00003.

    PubMed 14606782
  • Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod. 2008 Nov;34(11):1291-1301.e3. doi: 10.1016/j.joen.2008.07.028. Epub 2008 Sep 17.

    PubMed 18928835
  • KAKEHASHI S, STANLEY HR, FITZGERALD RJ. THE EFFECTS OF SURGICAL EXPOSURES OF DENTAL PULPS IN GERM-FREE AND CONVENTIONAL LABORATORY RATS. Oral Surg Oral Med Oral Pathol. 1965 Sep;20:340-9. doi: 10.1016/0030-4220(65)90166-0. No abstract available.

    PubMed 14342926
  • Zehnder M. Root canal irrigants. J Endod. 2006 May;32(5):389-98. doi: 10.1016/j.joen.2005.09.014.

    PubMed 16631834
  • Gu LS, Kim JR, Ling J, Choi KK, Pashley DH, Tay FR. Review of contemporary irrigant agitation techniques and devices. J Endod. 2009 Jun;35(6):791-804. doi: 10.1016/j.joen.2009.03.010.

    PubMed 19482174
  • Cardoso MG, de Oliveira LD, Koga-Ito CY, Jorge AO. Effectiveness of ozonated water on Candida albicans, Enterococcus faecalis, and endotoxins in root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Mar;105(3):e85-91. doi: 10.1016/j.tripleo.2007.10.006.

    PubMed 18280954
  • Vianna ME, Horz HP, Conrads G, Zaia AA, Souza-Filho FJ, Gomes BP. Effect of root canal procedures on endotoxins and endodontic pathogens. Oral Microbiol Immunol. 2007 Dec;22(6):411-8. doi: 10.1111/j.1399-302X.2007.00379.x.

    PubMed 17949345
  • Nair PN, Sjogren U, Krey G, Kahnberg KE, Sundqvist G. Intraradicular bacteria and fungi in root-filled, asymptomatic human teeth with therapy-resistant periapical lesions: a long-term light and electron microscopic follow-up study. J Endod. 1990 Dec;16(12):580-8. doi: 10.1016/S0099-2399(07)80201-9.

    PubMed 2094761
  • Oliveira LD, Carvalho CA, Carvalho AS, Alves Jde S, Valera MC, Jorge AO. Efficacy of endodontic treatment for endotoxin reduction in primarily infected root canals and evaluation of cytotoxic effects. J Endod. 2012 Aug;38(8):1053-7. doi: 10.1016/j.joen.2012.04.015. Epub 2012 Jun 8.

    PubMed 22794204
  • Valera MC, da Rosa JA, Maekawa LE, de Oliveira LD, Carvalho CA, Koga-Ito CY, Jorge AO. Action of propolis and medications against Escherichia coli and endotoxin in root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Oct;110(4):e70-4. doi: 10.1016/j.tripleo.2010.01.029.

    PubMed 20868987
  • Bystrom A, Sundqvist G. The antibacterial action of sodium hypochlorite and EDTA in 60 cases of endodontic therapy. Int Endod J. 1985 Jan;18(1):35-40. doi: 10.1111/j.1365-2591.1985.tb00416.x. No abstract available.

    PubMed 3922900
  • Dametto FR, Ferraz CC, Gomes BP, Zaia AA, Teixeira FB, de Souza-Filho FJ. In vitro assessment of the immediate and prolonged antimicrobial action of chlorhexidine gel as an endodontic irrigant against Enterococcus faecalis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Jun;99(6):768-72. doi: 10.1016/j.tripleo.2004.08.026.

    PubMed 15897866
  • Estrela C, Sydney GB, Pesce HF, Felippe Junior O. Dentinal diffusion of hydroxyl ions of various calcium hydroxide pastes. Braz Dent J. 1995;6(1):5-9.

    PubMed 8688650
  • Gomes BP, Ferraz CC, Garrido FD, Rosalen PL, Zaia AA, Teixeira FB, de Souza-Filho FJ. Microbial susceptibility to calcium hydroxide pastes and their vehicles. J Endod. 2002 Nov;28(11):758-61. doi: 10.1097/00004770-200211000-00003.

    PubMed 12470019

Questions about this trial

What is this clinical trial studying?

A study testing Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting and Calcium Hydroxide Paste - Non-Setting in people with Necrotic Pulp, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohammed Saadi Alarbeed, master degree candidate (+201023455553, mohammed-saadi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pain (time frame: 4, 24, 48 hrs and 2 weeks after completion of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03009006, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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