Periapical PeriodontitisNCT04978545
The Effect of Ca(OH)2 in Apical Periodontitis
A study testing calciumhydroxide, intracanal medicament and chlorhexidine, intracanal medicament in people with Periapical Periodontitis and Polymerase Chain Reaction, run by Seyda Ersahan, DDS, PhD at 1 site in Turkey (Türkiye).
Trial summary
Aim of the present study was to determine the intraradicular microbiota of previously root canal-treated teeth with apical periodontitis using droplet digital polymerase chain reaction (ddPCR) and to investigate the antibacterial effectiveness of different intracanal medicaments [Ca(OH)2 and CHX] that will make… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis, Polymerase Chain Reaction, Intracanal Medicament
- What is being tested?
- calciumhydroxide, intracanal medicament and chlorhexidine, intracanal medicament
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Oct 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions
- Teeth with post-treatment apical periodontitis had endodontic therapy completed more than 2 years earlier and required retreatment.
- Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm.
- Termini of the root canal fillings ranged from 0-4 mm short of the radiographic apex, with no overfilling.
- The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity.
- Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm.
Who cannot join
- teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth >4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Dentistry
Istanbul, Esenler
About this study
Official title: Potentializing the Effect of Calcium Hydroxide on Chemomechanical Preparation in Teeth with Post-treatment Apical Periodontitis: a Randomized Clinical Study
Aim of the present study was to determine the intraradicular microbiota of previously root canal-treated teeth with apical periodontitis using droplet digital polymerase chain reaction (ddPCR) and to investigate the antibacterial effectiveness of different intracanal medicaments [Ca(OH)2 and CHX] that will make classical chemomechanical preparation more effective. This superiority, parallel, randomized clinical trial was conducted in the clinic of the Endodontic Department, Faculty of Dentistry, Istanbul Medipol University, Istanbul. Sixteen patients with posttreatment apical periodontitis (one tooth each) were randomly allocated into two groups according to the intracanal medicament used (n=8, for each): calcium hydroxide (CH) and 2% chlorhexidine gel (CHX) group. Total bacterial loads, as well as the amount of Enterococcus faecalis (E.faecalis) were determined before (S1) and after (S2) chemomechanical preparation and finally, after intracanal medication (S3) by means of ddPCR.
Read the detailed description
Eligibility criteria The study population consisted of 16 patients (6 women and 10 men, aged 19-63 years, mean age 34.43) presenting to the endodontic clinic at Istanbul Medipol University Dental School, for nonsurgical endodontic retreatment of teeth with apical periodontitis lesions. Sixteen previously root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions were included in this study. Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm. Teeth with post-treatment apical periodontitis had endodontic therapy completed more than 2 years earlier and required retreatment. Termini of the root canal fillings ranged from 0-4 mm short of the radiographic apex, with no overfilling. The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity. Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm. Exclusion criteria were also applied, as follows: teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth >4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.
Root canal treatment procedures and sampling Rubber dam and an aseptic technique were used throughout the endodontic retreatment. After plaque removal and rubber dam isolation, the operative field was cleaned with 3% hydrogen peroxide and disinfected with 2.5% NaOCl solution. Then, all coronal restorations, posts and carious defects were removed and access preparation was completed when the root canal filling was properly exposed. Afterwards, the tooth (including the pulp chamber), clamp, and adjacent rubber dam were once again disinfected with 2.5% NaOCl, followed by inactivation with 10% sodium thiosulfate in order to avoid interference with bacteriological sampling. Sterility control samples (SR1) were taken from the tooth surface with a sterile Omni Swab (Whatman FTA, Sigma-Aldrich) with an ejectable head. Paper points were transferred to cryotubes containing phosphate buffered saline (PBS) solution stored at -20°C. In each case, a single root canal was sampled in order to confine the microbial evaluation to a single ecological environment. In multirooted teeth, the root with the periapical lesion was selected. If there were periapical lesions in all roots, the wider canal was selected. Two of the canals included in this study were from single-rooted teeth, 3 were buccal canals in maxillary premolars, 1 palatal canal in maxillary molar, and 10 distal canals in mandibular molars.
Old root fillings were removed using Gates-Glidden drills (Dentsply Maillefer, Ballaigues, Switzerland) and endodontic files without the use of chemical solvents. The working length (WL) was established 1 mm short of the apical foramen with an apex locator (Raypex6; VDW GmbH, Munich, Germany) and then periapical radiographs were taken to ensure that all filling material was removed. Irrigation with sterile saline solution was performed in order to remove any remaining materials and to moisten the canal prior to sample collection. Next, the canal was left filled with saline, and a small hand instrument was placed at the WL and used to gently file the canal walls. An initial microbiologic sample (S1) was taken from the root canal with sterile paper points consecutively placed at the WL. Three sterile paper points were inserted into the root canal for sampling. Each paper point was left in the canal for about 1 minute. Both the paper points and the endodontic hand instument, without the handle, were transferred to cryotubes containing 300 μL of PBS solution stored at -20°C. The samples were transferred to genetic analysis laboratory for further analysis in cold chain.
Root canals were prepared by using the Revo S files and copious irrigation with 2.5% NaOCl. The canals were apically enlarged to size 35 (AS35) at the working length. Between each instrument change, the root canal was irrigated with 5 mL of 2.5% NaOCl solution. Hence, a total of 30 mL of the irrigating solution was used. After instrumentation was completed, the smear layer was removed with 17% EDTA, which was left in the canal for 3 minutes, followed by 2.5% NaOCl. The root canal was dried with sterile paper points and flushed with 2 mL of 10% sodium thiosulfate for 1 min to inactivate the NaOCl solution. Next, a sample (S2) was taken from the canals as described for S1. After preparation, the canal was medicated with either the Ca(OH)2 or 2% chlorhexidine gel based on the study group. In the CH group, calcium hydroxide powder (Calxyl; OCO Products, Dirnstein, Germany) was mixed with saline in a ratio 1:1 and the paste was inserted into the canal by using lentulo spirals (Malleifer-Dentsply). In CHX group, chlorhexidine gel 2% (Gluco-Chex 2% gel, Cerkamed, Stalowa Wola, Polland) was placed into the root canals of this group with an Ultradent Capillary Tip (Ultradent products). All root canals of the 2 above groups were sealed with a 1-mm cotton pellet and at least 3 mm layer of temporary filling material (Cavit G; 3M ESPE AG, Seefeld, Germany).
After 7 days, the tooth was isolated, the temporary restoration removed, and disinfection procedures of the operative field were performed following the same protocol used in the first visit. A new control sample of the dental crown and dentin surrounding the pulp chamber was obtained (SR2). The medication was removed with 5 mL of saline solution and by carefully filing the canal with a master apical file. For the groups using Ca(OH)2, the calcium hydroxide antimicrobial activity was neutralized with 0.5% citric acid for a period of 1 minute, which was then removed with 5 mL of saline solution. Thus, for the groups with CHX gel, the medicament was neutralized with a mixture of 0.3% L-α-lecithin and 3% Tween 80 (Zamany A, Spangberg LS (2002) An effective method of inactivating chlorhexidine. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontics). Next, the root canals were irrigated with 2 mL of saline solution. The post medicament sample (S3) was obtained in the same way as the pre-medicament sample was collected and sent for the PCR analysis.
After the final sampling procedure, smear layer was removed by irrigation with 5 mL17% EDTA and then, a final rinse with 10 mL distilled water. Completion of the root canal treatment proceeded with root filling using lateral condensation of gutta-percha. Access cavities were restored with composite resin (Z250, 3M Corporation, Saint Paul, MN, USA), and a final radiograph was taken.
Total bacterial loads, as well as the amount of Enterococcus faecalis were determined before instrumentation, after instrumentation and use of the intracanal medicaments, by means of ddPCR.
Genomic DNA isolation and measurement of DNA concentration DNA was extracted using the QIAamp DNA Mini Kit (Qiagen, Germany) following the protocol recommended by the manufacturer. Before DNA isolation, samples (the tubes with paper points) were digested at 50-60°C BY vortexING for 30s in every 10 min in order to ensure disaggregation of all bacteria into the PBS solution. Afterwards, the paper points were aseptically removed from the suspension and, the bacterial suspension was pelleted by centrifugation for 10 min at 5000 g. The pellet was then resuspended in 180 µl buffer ATL supplied by QIAamp DNA Mini Kit (QIAGEN GmbH, Hilden, Germany) and 20 µl proteinase K (20 mg/ml) was added. Samples were incubated for 3 h at 56°C. Subsequently, total bacterial genomic DNA was isolated according to the protocol of the QIAamp DNA Mini Kit. The final volume of DNA solution of each sample was 150 μL and was taken into account during calculation. DNA concentration (absorbance at 260 nm) was determined with a spectrophotometer (Promega Quantifluor).
Amplification of 16S rRNA genes Primers for Universal and Enterococcus 16S rRNA genes were designed in this study. After DNA extraction of samples with QIAamp DNA Mini Kit, 700-800 bp of 16S rRNA sequences were amplified by using universal E8F forward primer (5'-AGAGTTTGATCCTGGCTCAG-3') and universal E1115R reverse primer (5'-AGGGTTGCGCTCGTTG-3') 59. The final volume of PCR reactions for each isolated bacterial strain was adjusted to 25 µl. The amplification reactions of 16S rRNA genes were performed with the following conditions. 1 cycle of predenaturation at 95°C for 3 minutes, 35 cycles of 95°C for 30 seconds, 55°C for 30 seconds, and 72°C for 30 seconds which continue with a final extension step at 72°C for 10 minutes.
The PCR products were analyzed by electrophoresis using 2% agarose gel (containing ethidium bromide) in Tris/BoratE/EDTA (TBE) buffer, with gels being analyzed under ultraviolet light (at 140V for 20 minutes). Their images were visualized under ultraviolet illumination. In addition, the control and optimization of primers to be used for ddPCR was also done in conventional PCR.
Purification and Sequencing of the 16S rRNA Gene After the PCR reactions, the purification of PCR products is done by hydrolyzing the excess primers and nucleotides with ExoSap-IT (Thermo, PN: 78201.1.ML) containing Exonuclease I and Alkaline Phosphatase enzymes. 2 µl of ExoSap-IT was mixed with 5 µl of PCR product for each sample. The ExoSap reaction is performed at 37 °C for 15 minutes (enzyme activation) followed by 15 minutes (inactivation) at 80 °C. Sequencing reactions were performed by using Bigdye™ Terminator v3.1 cycle sequencing kit (Thermo). The reactions were performed according to the kit manual for all isolated strains.
After purification of the products with Exosap, the sequence reaction was performed with BigDye Terminator v3.1 Cycle Sequencing Kit (Thermo) under the following conditions. After the sequence PCR, BigDye products were purified by colon method. Zymo ZR DNA Sequencing Clean-up Kit (Zymo Research, USA) was used for this process. All samples were purified in accordance with the protocol given in the kit and executed on the 3130XL genetic analyzer.
Droplet Digital PCR (ddPCR) Droplet Digital PCR (ddPCR) was performed using primers designed according to the 16S rRNA region specific to the total bacteria and Enterococcus faecalis species, after sequencing, absolute quantitation from the bacterial species found in the paper-point sample. Primer pairs were 16S-F-5'-AGGGAATCTTCSGCAATGGG-3' and 16S-R-5'-ACGCCCAATAAATCCGGACA-'3 for total bacteria and ENT-F-5'-CGCTTCTTTCCTCCCGAGT-3' and ENT-R-5'-GCCATGCGGCATAAACTG-3' primer pairs for Enterococcus Faecalis. In the PCR reaction, amplicons amplified with unmarked primer pairs were analyzed by labeling with Eva-Green dye. For absolute quantitation of Enterococcus and total 16S rRNA, PCR was performed with two primer pairs from the same sample. 20 µL of PCR mix containing 10 µL of 2X ddPCR EvaGreen Supermix (Bio-Rad, cat. no. 1864034), 9 µL of nuclease-free water, 0.25 µL of both forward and reverse primer and 2 ng of DNA from each sample Thermal cycling conditions were: 95◦C for 5 min, then 40 cycles of 95◦C for 30 s and 60◦C for 1 min and two final steps at 4◦C for 5 minutes and 90◦C for 5minutes with a 4◦C infinite hold. After PCR was completed, the sealed plate was transferred into the plate holder of the QX200 Droplet Reader (Bio-Rad, cat. no. 1864003).
- Conditions
- Periapical Periodontitis, Polymerase Chain Reaction, Intracanal Medicament, Enterococcus Faecalis Infection
- Being tested
- calciumhydroxide, intracanal medicament, chlorhexidine, intracanal medicament
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calciumhydroxide, intracanal medicamentOther
In the CH group, calcium hydroxide powder (Calxyl; OCO Products, Dirnstein, Germany) was mixed with saline in a ratio 1:1 and the paste was inserted into the canal by using lentulo spirals (Malleifer-Dentsply).
chlorhexidine, intracanal medicamentOther
, chlorhexidine gel 2% (Gluco-Chex 2% gel, Cerkamed, Stalowa Wola, Polland) was placed into the root canals of this group with an Ultradent Capillary Tip (Ultradent products).
| Study group | Role | What they receive |
|---|---|---|
| calciumhydroxide | Experimental | Participants received calciumhydroxide as an intracanal medicament for a one week period Receives: Other: calciumhydroxide, intracanal medicament |
| chlorhexidine | Experimental | Participants received chlorhexidine gel as an intracanal medicament for a one week period Receives: Other: chlorhexidine, intracanal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sequence analysis of 16S rRNA genes by the Sanger sequencing
the Sanger sequencing
Measured: change from baseline to postoperative 7 days
, the quantitation of total bacteria and E.faecalis in 5 different samples (SR1, S1, S2, SR2 and S3) taken from teeth were measured using the ddPCR
droplet digital PCR
Measured: change from baseline to postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jan 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seyda Ersahan, DDS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital
- Investigators
- Seyda Ersahan, Assoc.Prof., Principal investigator, IstanbulMedipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978545
- Sponsor's protocol ID
- Interventional
- Status last verified
- May 2023
- First submitted
- 28 Jun 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potentializing the Effect of Calcium Hydroxide on Chemomechanical Preparation in Teeth with Post-treatment Apical Periodontitis: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04978545
- Acronym / sponsor ID
- Interventional
- Conditions
- Periapical Periodontitis, Polymerase Chain Reaction, Intracanal Medicament, Enterococcus Faecalis Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seyda Ersahan, DDS, PhDUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the present study was to determine the intraradicular microbiota of previously root canal-treated teeth with apical periodontitis using droplet digital polymerase chain reaction (ddPCR) and to investigate the antibacterial effectiveness of different intracanal medicaments [Ca(OH)2 and CHX] that will make classical chemomechanical preparation more effective. This superiority, parallel, randomized clinical trial was conducted in the clinic of the Endodontic Department, Faculty of Dentistry, Istanbul Medipol University, Istanbul. Sixteen patients with posttreatment apical periodontitis (one tooth each) were randomly allocated into two groups according to the intracanal medicament used (n=8, for each): calcium hydroxide (CH) and 2% chlorhexidine gel (CHX) group. Total bacterial loads, as well as the amount of Enterococcus faecalis (E.faecalis) were determined before (S1) and after (S2) chemomechanical preparation and finally, after intracanal medication (S3) by means of ddPCR.
Detailed description
Eligibility criteria The study population consisted of 16 patients (6 women and 10 men, aged 19-63 years, mean age 34.43) presenting to the endodontic clinic at Istanbul Medipol University Dental School, for nonsurgical endodontic retreatment of teeth with apical periodontitis lesions. Sixteen previously root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions were included in this study. Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm. Teeth with post-treatment apical periodontitis had endodontic therapy completed more than 2 years earlier and required retreatment. Termini of the root canal fillings ranged from 0-4 mm short of the radiographic apex, with no overfilling. The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity. Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm. Exclusion criteria were also applied, as follows: teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth >4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.
Root canal treatment procedures and sampling Rubber dam and an aseptic technique were used throughout the endodontic retreatment. After plaque removal and rubber dam isolation, the operative field was cleaned with 3% hydrogen peroxide and disinfected with 2.5% NaOCl solution. Then, all coronal restorations, posts and carious defects were removed and access preparation was completed when the root canal filling was properly exposed. Afterwards, the tooth (including the pulp chamber), clamp, and adjacent rubber dam were once again disinfected with 2.5% NaOCl, followed by inactivation with 10% sodium thiosulfate in order to avoid interference with bacteriological sampling. Sterility control samples (SR1) were taken from the tooth surface with a sterile Omni Swab (Whatman FTA, Sigma-Aldrich) with an ejectable head. Paper points were transferred to cryotubes containing phosphate buffered saline (PBS) solution stored at -20°C. In each case, a single root canal was sampled in order to confine the microbial evaluation to a single ecological environment. In multirooted teeth, the root with the periapical lesion was selected. If there were periapical lesions in all roots, the wider canal was selected. Two of the canals included in this study were from single-rooted teeth, 3 were buccal canals in maxillary premolars, 1 palatal canal in maxillary molar, and 10 distal canals in mandibular molars.
Old root fillings were removed using Gates-Glidden drills (Dentsply Maillefer, Ballaigues, Switzerland) and endodontic files without the use of chemical solvents. The working length (WL) was established 1 mm short of the apical foramen with an apex locator (Raypex6; VDW GmbH, Munich, Germany) and then periapical radiographs were taken to ensure that all filling material was removed. Irrigation with sterile saline solution was performed in order to remove any remaining materials and to moisten the canal prior to sample collection. Next, the canal was left filled with saline, and a small hand instrument was placed at the WL and used to gently file the canal walls. An initial microbiologic sample (S1) was taken from the root canal with sterile paper points consecutively placed at the WL. Three sterile paper points were inserted into the root canal for sampling. Each paper point was left in the canal for about 1 minute. Both the paper points and the endodontic hand instument, without the handle, were transferred to cryotubes containing 300 μL of PBS solution stored at -20°C. The samples were transferred to genetic analysis laboratory for further analysis in cold chain.
Root canals were prepared by using the Revo S files and copious irrigation with 2.5% NaOCl. The canals were apically enlarged to size 35 (AS35) at the working length. Between each instrument change, the root canal was irrigated with 5 mL of 2.5% NaOCl solution. Hence, a total of 30 mL of the irrigating solution was used. After instrumentation was completed, the smear layer was removed with 17% EDTA, which was left in the canal for 3 minutes, followed by 2.5% NaOCl. The root canal was dried with sterile paper points and flushed with 2 mL of 10% sodium thiosulfate for 1 min to inactivate the NaOCl solution. Next, a sample (S2) was taken from the canals as described for S1. After preparation, the canal was medicated with either the Ca(OH)2 or 2% chlorhexidine gel based on the study group. In the CH group, calcium hydroxide powder (Calxyl; OCO Products, Dirnstein, Germany) was mixed with saline in a ratio 1:1 and the paste was inserted into the canal by using lentulo spirals (Malleifer-Dentsply). In CHX group, chlorhexidine gel 2% (Gluco-Chex 2% gel, Cerkamed, Stalowa Wola, Polland) was placed into the root canals of this group with an Ultradent Capillary Tip (Ultradent products). All root canals of the 2 above groups were sealed with a 1-mm cotton pellet and at least 3 mm layer of temporary filling material (Cavit G; 3M ESPE AG, Seefeld, Germany).
After 7 days, the tooth was isolated, the temporary restoration removed, and disinfection procedures of the operative field were performed following the same protocol used in the first visit. A new control sample of the dental crown and dentin surrounding the pulp chamber was obtained (SR2). The medication was removed with 5 mL of saline solution and by carefully filing the canal with a master apical file. For the groups using Ca(OH)2, the calcium hydroxide antimicrobial activity was neutralized with 0.5% citric acid for a period of 1 minute, which was then removed with 5 mL of saline solution. Thus, for the groups with CHX gel, the medicament was neutralized with a mixture of 0.3% L-α-lecithin and 3% Tween 80 (Zamany A, Spangberg LS (2002) An effective method of inactivating chlorhexidine. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontics). Next, the root canals were irrigated with 2 mL of saline solution. The post medicament sample (S3) was obtained in the same way as the pre-medicament sample was collected and sent for the PCR analysis.
After the final sampling procedure, smear layer was removed by irrigation with 5 mL17% EDTA and then, a final rinse with 10 mL distilled water. Completion of the root canal treatment proceeded with root filling using lateral condensation of gutta-percha. Access cavities were restored with composite resin (Z250, 3M Corporation, Saint Paul, MN, USA), and a final radiograph was taken.
Total bacterial loads, as well as the amount of Enterococcus faecalis were determined before instrumentation, after instrumentation and use of the intracanal medicaments, by means of ddPCR.
Genomic DNA isolation and measurement of DNA concentration DNA was extracted using the QIAamp DNA Mini Kit (Qiagen, Germany) following the protocol recommended by the manufacturer. Before DNA isolation, samples (the tubes with paper points) were digested at 50-60°C BY vortexING for 30s in every 10 min in order to ensure disaggregation of all bacteria into the PBS solution. Afterwards, the paper points were aseptically removed from the suspension and, the bacterial suspension was pelleted by centrifugation for 10 min at 5000 g. The pellet was then resuspended in 180 µl buffer ATL supplied by QIAamp DNA Mini Kit (QIAGEN GmbH, Hilden, Germany) and 20 µl proteinase K (20 mg/ml) was added. Samples were incubated for 3 h at 56°C. Subsequently, total bacterial genomic DNA was isolated according to the protocol of the QIAamp DNA Mini Kit. The final volume of DNA solution of each sample was 150 μL and was taken into account during calculation. DNA concentration (absorbance at 260 nm) was determined with a spectrophotometer (Promega Quantifluor).
Amplification of 16S rRNA genes Primers for Universal and Enterococcus 16S rRNA genes were designed in this study. After DNA extraction of samples with QIAamp DNA Mini Kit, 700-800 bp of 16S rRNA sequences were amplified by using universal E8F forward primer (5'-AGAGTTTGATCCTGGCTCAG-3') and universal E1115R reverse primer (5'-AGGGTTGCGCTCGTTG-3') 59. The final volume of PCR reactions for each isolated bacterial strain was adjusted to 25 µl. The amplification reactions of 16S rRNA genes were performed with the following conditions. 1 cycle of predenaturation at 95°C for 3 minutes, 35 cycles of 95°C for 30 seconds, 55°C for 30 seconds, and 72°C for 30 seconds which continue with a final extension step at 72°C for 10 minutes.
The PCR products were analyzed by electrophoresis using 2% agarose gel (containing ethidium bromide) in Tris/BoratE/EDTA (TBE) buffer, with gels being analyzed under ultraviolet light (at 140V for 20 minutes). Their images were visualized under ultraviolet illumination. In addition, the control and optimization of primers to be used for ddPCR was also done in conventional PCR.
Purification and Sequencing of the 16S rRNA Gene After the PCR reactions, the purification of PCR products is done by hydrolyzing the excess primers and nucleotides with ExoSap-IT (Thermo, PN: 78201.1.ML) containing Exonuclease I and Alkaline Phosphatase enzymes. 2 µl of ExoSap-IT was mixed with 5 µl of PCR product for each sample. The ExoSap reaction is performed at 37 °C for 15 minutes (enzyme activation) followed by 15 minutes (inactivation) at 80 °C. Sequencing reactions were performed by using Bigdye™ Terminator v3.1 cycle sequencing kit (Thermo). The reactions were performed according to the kit manual for all isolated strains.
After purification of the products with Exosap, the sequence reaction was performed with BigDye Terminator v3.1 Cycle Sequencing Kit (Thermo) under the following conditions. After the sequence PCR, BigDye products were purified by colon method. Zymo ZR DNA Sequencing Clean-up Kit (Zymo Research, USA) was used for this process. All samples were purified in accordance with the protocol given in the kit and executed on the 3130XL genetic analyzer.
Droplet Digital PCR (ddPCR) Droplet Digital PCR (ddPCR) was performed using primers designed according to the 16S rRNA region specific to the total bacteria and Enterococcus faecalis species, after sequencing, absolute quantitation from the bacterial species found in the paper-point sample. Primer pairs were 16S-F-5'-AGGGAATCTTCSGCAATGGG-3' and 16S-R-5'-ACGCCCAATAAATCCGGACA-'3 for total bacteria and ENT-F-5'-CGCTTCTTTCCTCCCGAGT-3' and ENT-R-5'-GCCATGCGGCATAAACTG-3' primer pairs for Enterococcus Faecalis. In the PCR reaction, amplicons amplified with unmarked primer pairs were analyzed by labeling with Eva-Green dye. For absolute quantitation of Enterococcus and total 16S rRNA, PCR was performed with two primer pairs from the same sample. 20 µL of PCR mix containing 10 µL of 2X ddPCR EvaGreen Supermix (Bio-Rad, cat. no. 1864034), 9 µL of nuclease-free water, 0.25 µL of both forward and reverse primer and 2 ng of DNA from each sample Thermal cycling conditions were: 95◦C for 5 min, then 40 cycles of 95◦C for 30 s and 60◦C for 1 min and two final steps at 4◦C for 5 minutes and 90◦C for 5minutes with a 4◦C infinite hold. After PCR was completed, the sealed plate was transferred into the plate holder of the QX200 Droplet Reader (Bio-Rad, cat. no. 1864003).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calciumhydroxide | Experimental | Other: calciumhydroxide, intracanal medicamentParticipants received calciumhydroxide as an intracanal medicament for a one week period |
| chlorhexidine | Experimental | Other: chlorhexidine, intracanal medicamentParticipants received chlorhexidine gel as an intracanal medicament for a one week period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions
- Teeth with post-treatment apical periodontitis had endodontic therapy completed more than 2 years earlier and required retreatment.
- Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm.
- Termini of the root canal fillings ranged from 0-4 mm short of the radiographic apex, with no overfilling.
- The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity.
Key exclusion criteria (1 listed)
- teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth >4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calciumhydroxide, intracanal medicamentIn the CH group, calcium hydroxide powder (Calxyl; OCO Products, Dirnstein, Germany) was mixed with saline in a ratio 1:1 and the paste was inserted into the canal by using lentulo spirals (Malleifer-Dentsply). | Other | calciumhydroxide |
| chlorhexidine, intracanal medicament, chlorhexidine gel 2% (Gluco-Chex 2% gel, Cerkamed, Stalowa Wola, Polland) was placed into the root canals of this group with an Ultradent Capillary Tip (Ultradent products). | Other | chlorhexidine |
Primary outcome
the sequence analysis of 16S rRNA genes by the Sanger sequencing
Time frame: change from baseline to postoperative 7 days
the Sanger sequencing
, the quantitation of total bacteria and E.faecalis in 5 different samples (SR1, S1, S2, SR2 and S3) taken from teeth were measured using the ddPCR
Time frame: change from baseline to postoperative 7 days
droplet digital PCR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda Ersahan, Assoc.Prof. principal investigator
IstanbulMedipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calciumhydroxide, intracanal medicament and chlorhexidine, intracanal medicament in people with Periapical Periodontitis and Polymerase Chain Reaction, run by Seyda Ersahan, DDS, PhD at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sequence analysis of 16S rRNA genes by the Sanger sequencing (time frame: change from baseline to postoperative 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.