Regenerative EndodonticsNCT05581706
Regenerative Endodontics Using Different Intracanal Medicaments on Radiographic Outcomes and Periapical MMP-8 Levels
A study testing Place the freshly prepared calcium hydroxide in to the root canals, Place the freshly prepared double antibiotic paste in to the root canals and Taking standart periapical radiography with film holder in people with Regenerative Endodontics, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Two-session regenerative endodontic treatment was applied to 20 immature mandibular first molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis. At the end of the first session, calcium hydroxide [Ca(OH)2] was applied to 10 randomly selected teeth and double antibiotic paste (DAP)… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Regenerative Endodontics
- What is being tested?
- Place the freshly prepared calcium hydroxide in to the root canals, Place the freshly prepared double antibiotic paste in to the root canals and Taking standart periapical radiography with film holder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 1 Mar 2021
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children with irreversible pulpitis with symptomatic apical periodontitis (SIP-SAP), indication for RET and informed consent from the patients.
Who cannot join
- Children with extra oral swelling or luxation with a deep periodontal pocket and whom application of RET was contraindicated.
- The teeth were indicated for vital pulp therapy (assesed during treatment)
- Children who have used antibiotics in the past 3 months and are uncooperative during treatment
- Children who have used any painkillers during the treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry Pediatric Dentistry
Izmir
About this study
Official title: The Effects of Calcium Hydroxide and Double Antibiotic Paste on Radiographic Outcomes and Periapical MMP-8 Levels in Regenerative Endodontic Procedures: A Randomized Clinical Trial
Two-session regenerative endodontic treatment was applied to 20 immature mandibular first molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis. At the end of the first session, calcium hydroxide [Ca(OH)2] was applied to 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were applied to the other 10 teeth. The effects of intracanal medicaments on periapical MMP-8 levels were determined by immunofluorometric assay (IFMA) in periapical tissue fluid samples taken from the distal root canal in the first and second sessions.
Read the detailed description
The aim of the study was to investigate the effects of two different intracanal medicaments used during regenerative endodontic treatment (RET) on periapical MMP-8 in relation to the radiological outcomes of RET. After local anesthesia and rubber dam isolation were provided, disinfection procedures were applied gently in accordance with the current RET protocol of American Association of Endodontics (AAE) on the molar teeth. Periapical tissue fluid samples were taken with paper points placed to protrude 2 mm from the distal root canal tip. Calcium hydroxide [Ca(OH)2] was placed in 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were placed in the other 10 teeth. Fourteen days later in the second session, the final sampling procedure was performed as in the first session. Then, the treatment was completed according to the current RET protocol of AAE and permanent restorations were made. The success of the treatment and its effect on root development were evaluated by comparing the standard radiographs taken at the end of the treatment and 12 months follow up. MMP-8 levels were measured by immunofluorometric assay (IFMA) in the periapical tissue fluid samples. First and second session MMP-8 levels were compared according to the groups of medicaments [Ca(OH)2 and DAP groups] placed in the root canals.
- Conditions
- Regenerative Endodontics
- Being tested
- Place the freshly prepared calcium hydroxide in to the root canals, Place the freshly prepared double antibiotic paste in to the root canals, Taking standart periapical radiography with film holder, Sample collection for immunofluorometric assay
- Keywords
- regenerative endodontics, intracanal medicaments, MMP-8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Place the freshly prepared calcium hydroxide in to the root canalsCombination product
Also called Ca(OH)2 medicament
Calcium hydroxide (Merck, Darmstadt, Germany): prepared by mixing with sterile distilled water and then placed in the coronal 1/3 of the root canals.
Place the freshly prepared double antibiotic paste in to the root canalsCombination product
Also called DAP medicament
Double antibiotic paste (DAP): metronidazole (Flagyl, Sanofi-Aventis, Turkey) and ciprofloxacin (Cipro, Biofarma, Turkey) powdered antibiotics were stored and sealed in airtight containers. The same amount of each drug powder (1:1) was mixed and the mixed samples were combined with sterile distilled water to form an ointment. DAP was introduced in roots canals using a lentulo to fill the entire root canal space.
Taking standart periapical radiography with film holderDiagnostic test
Also called Determination of rooth lenght, rooth width, radiographic root area
Post-operative periapical radiographs were obtained with Digora Optime SPP system (Soredex Corp., Tuusula, Finland) using intraoral film holders to keep the plates parallel to the long axis of the teeth. A size #2 SPP was used for all exposures. SPPs were exposed with a Gendex Oralix DC dental x-ray unit (Gendex Dental Systems, Milan, Italy) operating at 60 kVp, 7 mA, 0.25 sec. and the plates were scanned immediately after exposure. The clinical and radiographical follow up was performed on 12th months.
Image-J program (version 1.47, National Institutes of Health, Bethesda, MD) with TurboReg plug-in (Biomedical Imaging Group, Swiss Federal Institute of Technology, Lausanne, Switzerland) was used to determine the increase in root length, root width, and radiographic root area at 12th month follow up.
Sample collection for immunofluorometric assayOther
Also called IFMA
Periapical exudate samples were collected at the beginning of the RET and at 14th day. MMP-8 levels were measured by immunofluorometric assay (IFMA). Briefly, two monoclonal MMP-8-specific antibodies, 8708 and 8706 (Oy Medix Biochemica Ab, Espoo, Finland) were used as catching antibody and tracer antibody, respectively. Samples were diluted in enzyme buffer (50 mM Tris-HCl, pH 7.5; 0.2 mM NaCl, 1 mM CaCl2). Twenty microlitres of samples and 80 μl of assay buffer (20 mM Tris-HCl, pH 7.5, 0.5 M NaCl, 5 mM CaCl2, 0.5% BSA, 0.05% sodium azide and 20 mg/l diethylenetriaminepentaacetic acid with 2 μg/ml normal mouse serum) were pipetted into the wells. The tracer antibody was labelled using europium chelate. After adding the enhancement solution, fluorescence was measured using a 1234 Delfia Research Fluorometer (Wallac, Turku, Finland).
| Study group | Role | What they receive |
|---|---|---|
| Regenerative endodontic treatment with calcium hydroxide | Active comparator | Regenerative endodontic treatment (RET) performed with procedures of American Association of Endodontics (AAE) in two sessions. At the end of the first session, periapical tissue fluid samples (baseline samples) were collected.
Calcium hydroxide medicament was prepared by mixing with sterile distilled water and then placed in the coronal 1/3 of the root canals.
In the second session (14 days after first treatment), the medicaments in the root canals were carefully removed with 5 ml sterile distilled water irrigation. Periapical tissue fluid samples were obtained from the distal canal using the same protocol as described previously (final samples). Then RET was finished according to the treatment protocol of AAE. Receives: Combination Product: Place the freshly prepared calcium hydroxide in to the root canals |
| Regenerative endodontic treatment with double antibiotic paste | Active comparator | Regenerative endodontic treatment (RET) performed with procedures of American Association of Endodontics (AAE) in two sessions. At the end of the first session, periapical tissue fluid samples (baseline samples) were collected.
Double antibiotic paste (DAP) was prepared by mixing same amount of metronidazole and ciprofloxacin powdered antibiotics (1:1) and combined with sterile distilled water to form an ointment. DAP was introduced in roots canals using a lentulo to fill the entire root canal space.
In the second session (14 days after first treatment) after removal of DAP in the root canals, periapical tissue fluid samples were obtained the same protocol as described previously (final samples). Then RET was finished according to the treatment protocol of AAE. Receives: Combination Product: Place the freshly prepared double antibiotic paste in to the root canals |
| Radiographic evaluation | Active comparator | Pre-operative, post-operative and final recall (12th months follow up) standart digital radiographs were taken from patients with film holder. The radiographs saved and transferred to Image J software (version 1.47, National Institutes of Health, Bethesda, MD). The standardized radiographs were further aligned using the TurboReg plugin (Biomedical Imaging Group, Swiss Federal Institute of Technology, Lausanne, Switzerland) within the Image J toolkit to minimize any distortions caused by variability in the angulation.
All images were calibrated according to size #2 SPP (vertical dimension 31 mm, horizontal dimension 41 mm) using the ''set scale'' option in Image J. Thereafter, the root lengths, root width and radiographic root area were measured on both preoperative and final recall images to evaluate treatment outcomes. Receives: Diagnostic Test: Taking standart periapical radiography with film holder |
| Periapical tissue exudate sample collection and Immunofluorometric assay MMP-8 | Active comparator | At the end of the first session, periapical tissue fluid samples (baseline samples) were collected by introducing 3 sterile #45 paper points into the root canal until 2 mm passing through the root apex from the distal canal. After waiting for 1 min, the paper points were withdrawn, the tip was cut from 4 mm and were transferred to sterile Eppendorf tubes. At the beginnign of the second session periapical tissue fluid samples were obtained from the distal canal using the same protocol as described in the first session (final samples).
Baseline and final MMP-8 concentrations were determined by a time-resolved immunofluorometric assay (IFMA). The monoclonal MMP-8 specific antibodies 8708 and 8706 (Oy Medix Biochemica Ab, Espoo, Finland) were used as a catching antibody and a tracer antibody, respectively. The tracer antibody was labeled using europium-chelate Receives: Other: Sample collection for immunofluorometric assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing according to presence of clinical symptoms
All patients were called for follow up visits. The clinical healing was determined by examining clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling, and mobility. All teeth were asymptomatic at follow up appointments. If one of these symptoms occurred, it could considered as failure.
Measured: 12 months
Periapical healing according to change in amount of root hard tissues
All periapical radiolucency detected due to apical periodontitis were healed. Significant increases in radiographic root length, root width and RRA was observed at 12th month.
Measured: 12 months
MMP-8 levels from periapical tissue fluid samples
There was a statistically significant increase in MMP-8 levels on day 14 compared to baseline in both Ca(OH)2 and DAP groups. The increase in MMP-8 levels was higher in the DAP group compared to Ca(OH)2 group, however no statistically significant difference was observed between 2 groups regarding the final (14th day) MMP-8 levels.
Measured: 14 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Sep 2017
- Primary completion1 Feb 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Regenerative EndodonticsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burç Pekpınarlı, Ege University
- Investigators
- Burç Pekpınarlı, Principal investigator, Ege University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581706
- Sponsor's protocol ID
- Regenerative Endodontics
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torabinejad M, Alexander A, Vahdati SA, Grandhi A, Baylink D, Shabahang S. Effect of Residual Dental Pulp Tissue on Regeneration of Dentin-pulp Complex: An In Vivo Investigation. J Endod. 2018 Dec;44(12):1796-1801. doi: 10.1016/j.joen.2018.09.005.
PubMed 30477665Sabeti M, Golchert K, Torabinejad M. Regeneration of Pulp-Dentin Complex in a Tooth with Symptomatic Irreversible Pulpitis and Open Apex Using Regenerative Endodontic Procedures. J Endod. 2021 Feb;47(2):247-252. doi: 10.1016/j.joen.2020.09.021. Epub 2020 Oct 10.
PubMed 33045267Wahlgren J, Salo T, Teronen O, Luoto H, Sorsa T, Tjaderhane L. Matrix metalloproteinase-8 (MMP-8) in pulpal and periapical inflammation and periapical root-canal exudates. Int Endod J. 2002 Nov;35(11):897-904. doi: 10.1046/j.1365-2591.2002.00587.x.
PubMed 12453017Kuula H, Salo T, Pirila E, Tuomainen AM, Jauhiainen M, Uitto VJ, Tjaderhane L, Pussinen PJ, Sorsa T. Local and systemic responses in matrix metalloproteinase 8-deficient mice during Porphyromonas gingivalis-induced periodontitis. Infect Immun. 2009 Feb;77(2):850-9. doi: 10.1128/IAI.00873-08. Epub 2008 Nov 24.
PubMed 19029300Bose R, Nummikoski P, Hargreaves K. A retrospective evaluation of radiographic outcomes in immature teeth with necrotic root canal systems treated with regenerative endodontic procedures. J Endod. 2009 Oct;35(10):1343-9. doi: 10.1016/j.joen.2009.06.021. Epub 2009 Aug 15.
PubMed 19801227Reynaud af Geijersstam A, Sorsa T, Stackelberg S, Tervahartiala T, Haapasalo M. Effect of E. faecalis on the release of serine proteases elastase and cathepsin G, and collagenase-2 (MMP-8) by human polymorphonuclear leukocytes (PMNs). Int Endod J. 2005 Sep;38(9):667-77. doi: 10.1111/j.1365-2591.2005.01011.x.
PubMed 16104981Martinho FC, Nascimento GG, Leite FR, Gomes AP, Freitas LF, Camoes IC. Clinical influence of different intracanal medications on Th1-type and Th2-type cytokine responses in apical periodontitis. J Endod. 2015 Feb;41(2):169-75. doi: 10.1016/j.joen.2014.09.028. Epub 2014 Nov 11.
PubMed 25453567Pekpinarli B, Kaval ME, Cogulu D, Ilhan B, Sorsa T, Tervahartiala T, Oncag O. The effect of calcium hydroxide and double antibiotic paste on radiographic outcomes and periapical MMP-8 levels in regenerative endodontic procedures: a randomized clinical trial. J Appl Oral Sci. 2024 Sep 20;32:e20240122. doi: 10.1590/1678-7757-2024-0122. eCollection 2024.
PubMed 39319904
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Calcium Hydroxide and Double Antibiotic Paste on Radiographic Outcomes and Periapical MMP-8 Levels in Regenerative Endodontic Procedures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05581706
- Acronym / sponsor ID
- Regenerative Endodontics
- Conditions
- Regenerative Endodontics
- Keywords
- regenerative endodontics, intracanal medicaments, MMP-8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 14 Oct 2022 (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.
Two-session regenerative endodontic treatment was applied to 20 immature mandibular first molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis. At the end of the first session, calcium hydroxide [Ca(OH)2] was applied to 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were applied to the other 10 teeth. The effects of intracanal medicaments on periapical MMP-8 levels were determined by immunofluorometric assay (IFMA) in periapical tissue fluid samples taken from the distal root canal in the first and second sessions.
Detailed description
The aim of the study was to investigate the effects of two different intracanal medicaments used during regenerative endodontic treatment (RET) on periapical MMP-8 in relation to the radiological outcomes of RET. After local anesthesia and rubber dam isolation were provided, disinfection procedures were applied gently in accordance with the current RET protocol of American Association of Endodontics (AAE) on the molar teeth. Periapical tissue fluid samples were taken with paper points placed to protrude 2 mm from the distal root canal tip. Calcium hydroxide [Ca(OH)2] was placed in 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were placed in the other 10 teeth. Fourteen days later in the second session, the final sampling procedure was performed as in the first session. Then, the treatment was completed according to the current RET protocol of AAE and permanent restorations were made. The success of the treatment and its effect on root development were evaluated by comparing the standard radiographs taken at the end of the treatment and 12 months follow up. MMP-8 levels were measured by immunofluorometric assay (IFMA) in the periapical tissue fluid samples. First and second session MMP-8 levels were compared according to the groups of medicaments [Ca(OH)2 and DAP groups] placed in the root canals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regenerative endodontic treatment with calcium hydroxide | Active comparator | Combination Product: Place the freshly prepared calcium hydroxide in to the root canalsRegenerative endodontic treatment (RET) performed with procedures of American Association of Endodontics (AAE) in two sessions. At the end of the first session, periapical tissue fluid samples (baseline samples) were collected. Calcium hydroxide medicament was prepared by mixing with sterile distilled water and then placed in the coronal 1/3 of the root canals. In the second session (14 days after first treatment), the medicaments in the root canals were carefully removed with 5 ml sterile distilled water irrigation. Periapical tissue fluid samples were obtained from the distal canal using the same protocol as described previously (final samples). Then RET was finished according to the treatment protocol of AAE. |
| Regenerative endodontic treatment with double antibiotic paste | Active comparator | Combination Product: Place the freshly prepared double antibiotic paste in to the root canalsRegenerative endodontic treatment (RET) performed with procedures of American Association of Endodontics (AAE) in two sessions. At the end of the first session, periapical tissue fluid samples (baseline samples) were collected. Double antibiotic paste (DAP) was prepared by mixing same amount of metronidazole and ciprofloxacin powdered antibiotics (1:1) and combined with sterile distilled water to form an ointment. DAP was introduced in roots canals using a lentulo to fill the entire root canal space. In the second session (14 days after first treatment) after removal of DAP in the root canals, periapical tissue fluid samples were obtained the same protocol as described previously (final samples). Then RET was finished according to the treatment protocol of AAE. |
| Radiographic evaluation | Active comparator | Diagnostic Test: Taking standart periapical radiography with film holderPre-operative, post-operative and final recall (12th months follow up) standart digital radiographs were taken from patients with film holder. The radiographs saved and transferred to Image J software (version 1.47, National Institutes of Health, Bethesda, MD). The standardized radiographs were further aligned using the TurboReg plugin (Biomedical Imaging Group, Swiss Federal Institute of Technology, Lausanne, Switzerland) within the Image J toolkit to minimize any distortions caused by variability in the angulation. All images were calibrated according to size #2 SPP (vertical dimension 31 mm, horizontal dimension 41 mm) using the ''set scale'' option in Image J. Thereafter, the root lengths, root width and radiographic root area were measured on both preoperative and final recall images to evaluate treatment outcomes. |
| Periapical tissue exudate sample collection and Immunofluorometric assay MMP-8 | Active comparator | Other: Sample collection for immunofluorometric assayAt the end of the first session, periapical tissue fluid samples (baseline samples) were collected by introducing 3 sterile #45 paper points into the root canal until 2 mm passing through the root apex from the distal canal. After waiting for 1 min, the paper points were withdrawn, the tip was cut from 4 mm and were transferred to sterile Eppendorf tubes. At the beginnign of the second session periapical tissue fluid samples were obtained from the distal canal using the same protocol as described in the first session (final samples). Baseline and final MMP-8 concentrations were determined by a time-resolved immunofluorometric assay (IFMA). The monoclonal MMP-8 specific antibodies 8708 and 8706 (Oy Medix Biochemica Ab, Espoo, Finland) were used as a catching antibody and a tracer antibody, respectively. The tracer antibody was labeled using europium-chelate |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children with irreversible pulpitis with symptomatic apical periodontitis (SIP-SAP), indication for RET and informed consent from the patients.
Key exclusion criteria (4 listed)
- Children with extra oral swelling or luxation with a deep periodontal pocket and whom application of RET was contraindicated.
- The teeth were indicated for vital pulp therapy (assesed during treatment)
- Children who have used antibiotics in the past 3 months and are uncooperative during treatment
- Children who have used any painkillers during the treatment
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 |
|---|---|---|
| Place the freshly prepared calcium hydroxide in to the root canalsAlso: Ca(OH)2 medicamentCalcium hydroxide (Merck, Darmstadt, Germany): prepared by mixing with sterile distilled water and then placed in the coronal 1/3 of the root canals. | Combination product | Regenerative endodontic treatment with calcium hydroxide |
| Place the freshly prepared double antibiotic paste in to the root canalsAlso: DAP medicamentDouble antibiotic paste (DAP): metronidazole (Flagyl, Sanofi-Aventis, Turkey) and ciprofloxacin (Cipro, Biofarma, Turkey) powdered antibiotics were stored and sealed in airtight containers. The same amount of each drug powder (1:1) was mixed and the mixed samples were combined with sterile distilled water to form an ointment. DAP was introduced in roots canals using a lentulo to fill the entire root canal space. | Combination product | Regenerative endodontic treatment with double antibiotic paste |
| Taking standart periapical radiography with film holderAlso: Determination of rooth lenght, rooth width, radiographic root areaPost-operative periapical radiographs were obtained with Digora Optime SPP system (Soredex Corp., Tuusula, Finland) using intraoral film holders to keep the plates parallel to the long axis of the teeth. A size #2 SPP was used for all exposures. SPPs were exposed with a Gendex Oralix DC dental x-ray unit (Gendex Dental Systems, Milan, Italy) operating at 60 kVp, 7 mA, 0.25 sec. and the plates were scanned immediately after exposure. The clinical and radiographical follow up was performed on 12th months. Image-J program (version 1.47, National Institutes of Health, Bethesda, MD) with TurboReg plug-in (Biomedical Imaging Group, Swiss Federal Institute of Technology, Lausanne, Switzerland) was used to determine the increase in root length, root width, and radiographic root area at 12th month follow up. | Diagnostic test | Radiographic evaluation |
| Sample collection for immunofluorometric assayAlso: IFMAPeriapical exudate samples were collected at the beginning of the RET and at 14th day. MMP-8 levels were measured by immunofluorometric assay (IFMA). Briefly, two monoclonal MMP-8-specific antibodies, 8708 and 8706 (Oy Medix Biochemica Ab, Espoo, Finland) were used as catching antibody and tracer antibody, respectively. Samples were diluted in enzyme buffer (50 mM Tris-HCl, pH 7.5; 0.2 mM NaCl, 1 mM CaCl2). Twenty microlitres of samples and 80 μl of assay buffer (20 mM Tris-HCl, pH 7.5, 0.5 M NaCl, 5 mM CaCl2, 0.5% BSA, 0.05% sodium azide and 20 mg/l diethylenetriaminepentaacetic acid with 2 μg/ml normal mouse serum) were pipetted into the wells. The tracer antibody was labelled using europium chelate. After adding the enhancement solution, fluorescence was measured using a 1234 Delfia Research Fluorometer (Wallac, Turku, Finland). | Other | Periapical tissue exudate sample collection and Immunofluorometric assay MMP-8 |
Primary outcome
Clinical healing according to presence of clinical symptoms
Time frame: 12 months
All patients were called for follow up visits. The clinical healing was determined by examining clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling, and mobility. All teeth were asymptomatic at follow up appointments. If one of these symptoms occurred, it could considered as failure.
Periapical healing according to change in amount of root hard tissues
Time frame: 12 months
All periapical radiolucency detected due to apical periodontitis were healed. Significant increases in radiographic root length, root width and RRA was observed at 12th month.
MMP-8 levels from periapical tissue fluid samples
Time frame: 14 day
There was a statistically significant increase in MMP-8 levels on day 14 compared to baseline in both Ca(OH)2 and DAP groups. The increase in MMP-8 levels was higher in the DAP group compared to Ca(OH)2 group, however no statistically significant difference was observed between 2 groups regarding the final (14th day) MMP-8 levels.
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 27 Dec 2023.
- Background: PubMed 30477665Torabinejad M, Alexander A, Vahdati SA, Grandhi A, Baylink D, Shabahang S. Effect of Residual Dental Pulp Tissue on Regeneration of Dentin-pulp Complex: An In Vivo Investigation. J Endod. 2018 Dec;44(12):1796-1801. doi: 10.1016/j.joen.2018.09.005.
- Background: PubMed 33045267Sabeti M, Golchert K, Torabinejad M. Regeneration of Pulp-Dentin Complex in a Tooth with Symptomatic Irreversible Pulpitis and Open Apex Using Regenerative Endodontic Procedures. J Endod. 2021 Feb;47(2):247-252. doi: 10.1016/j.joen.2020.09.021. Epub 2020 Oct 10.
- Background: PubMed 12453017Wahlgren J, Salo T, Teronen O, Luoto H, Sorsa T, Tjaderhane L. Matrix metalloproteinase-8 (MMP-8) in pulpal and periapical inflammation and periapical root-canal exudates. Int Endod J. 2002 Nov;35(11):897-904. doi: 10.1046/j.1365-2591.2002.00587.x.
- Background: PubMed 19029300Kuula H, Salo T, Pirila E, Tuomainen AM, Jauhiainen M, Uitto VJ, Tjaderhane L, Pussinen PJ, Sorsa T. Local and systemic responses in matrix metalloproteinase 8-deficient mice during Porphyromonas gingivalis-induced periodontitis. Infect Immun. 2009 Feb;77(2):850-9. doi: 10.1128/IAI.00873-08. Epub 2008 Nov 24.
- Background: PubMed 19801227Bose R, Nummikoski P, Hargreaves K. A retrospective evaluation of radiographic outcomes in immature teeth with necrotic root canal systems treated with regenerative endodontic procedures. J Endod. 2009 Oct;35(10):1343-9. doi: 10.1016/j.joen.2009.06.021. Epub 2009 Aug 15.
- Background: PubMed 16104981Reynaud af Geijersstam A, Sorsa T, Stackelberg S, Tervahartiala T, Haapasalo M. Effect of E. faecalis on the release of serine proteases elastase and cathepsin G, and collagenase-2 (MMP-8) by human polymorphonuclear leukocytes (PMNs). Int Endod J. 2005 Sep;38(9):667-77. doi: 10.1111/j.1365-2591.2005.01011.x.
- Background: PubMed 25453567Martinho FC, Nascimento GG, Leite FR, Gomes AP, Freitas LF, Camoes IC. Clinical influence of different intracanal medications on Th1-type and Th2-type cytokine responses in apical periodontitis. J Endod. 2015 Feb;41(2):169-75. doi: 10.1016/j.joen.2014.09.028. Epub 2014 Nov 11.
- Derived from this study: PubMed 39319904Pekpinarli B, Kaval ME, Cogulu D, Ilhan B, Sorsa T, Tervahartiala T, Oncag O. The effect of calcium hydroxide and double antibiotic paste on radiographic outcomes and periapical MMP-8 levels in regenerative endodontic procedures: a randomized clinical trial. J Appl Oral Sci. 2024 Sep 20;32:e20240122. doi: 10.1590/1678-7757-2024-0122. eCollection 2024.
- Individual participant dataSharing planned: No
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Apical Periodontitis, Periapical Diseases
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.
Burç Pekpınarlı principal investigator
Ege University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Place the freshly prepared calcium hydroxide in to the root canals, Place the freshly prepared double antibiotic paste in to the root canals and Taking standart periapical radiography with film holder in people with Regenerative Endodontics, run by Ege University 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 1 inclusion and 4 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 27 Dec 2023. 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?
Clinical healing according to presence of clinical symptoms (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT05581706, which also lists 8 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 27 Dec 2023.