Biological MarkersNCT04593238
Effect of Double Antibiotic Paste Versus Calcium Hydroxide on RANKL/OPG Levels
A study testing Double Antibiotic paste and Calcium Hydroxide Paste - Non-Setting in people with Biological Markers, run by Cairo University.
Trial summary
The aim of the present study is to evaluate the effect of double antibiotic paste when compared to Ca (OH)2, in terms of RANKL and OPG levels in chronic periapical lesions and correlate the results with periapical bone healing findings after a follow up period of one year. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Biological Markers
- What is being tested?
- Double Antibiotic paste and Calcium Hydroxide Paste - Non-Setting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Apr 2022
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are free from any physical or mental handicapping conditions and with no underlying systemic diseases.
- Age between 20-45years old.
- Males \& Females.
- Single canaled teeth:
- Diagnosed clinically with asymptomatic apical periodontitis.
- Absence of spontaneous pain
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- Size of periapical radiolucency: 2-4 mm (i.e. score 3 according to CBCT periapical index proposed by Estrela)30, including only the tested tooth.
- Patients who didn't use any NSAIDs or antibiotics for 1 month before treatment.
- Patients' acceptance to participate in the trial.
Who cannot join
- - Medically compromised patients.
- Pregnant women.
- Patients reporting bruxism or clenching.
- Patients allergic to ciprofloxacin or metronidazole.
- Teeth associated with acute periapical abscess and/or swelling.
- Greater than grade I mobility or pocket depth greater than 5mm.
Show all 10Show fewer
- Size of periapical radiolucency is less than 2 mm or greater than 4 mm.
- Non restorable teeth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
About this study
Official title: Effect of Double Antibiotic Paste Versus Calcium Hydroxide as Intra-canal Medications on RANKL/OPG Levels and Periapical Bone Healing in Patients With Asymptomatic Apical Periodontitis: A Randomized Clinical Trial
The aim of the present study is to evaluate the effect of double antibiotic paste when compared to Ca (OH)2, in terms of RANKL and OPG levels in chronic periapical lesions and correlate the results with periapical bone healing findings after a follow up period of one year.
Read the detailed description
Apical periodontitis is an inflammatory disease that occurs as a consequence of the bacterial infection of dental pulp tissue. It represents an inflammatory/immune pathogenesis affecting the periapical tissue including the surrounding bone. This periapical process is primarily initiated by bacterial infection in the necrotic pulp. Its persistence, progression to chronic lesions and destruction of bone structures are a consequence of the inability of host-defense mechanisms to eradicate infection. Periapical lesions are characterized histologically by fibrous and granulated tissue, infiltrated by different inflammatory cells.
Up to now the diagnosis and follow-up of asymptomatic apical periodontitis AAP is based on a clinical radiographic evaluation, however, this reflects the accumulated damage from previous episodes of periodontal tissue destruction. Moreover, the clinical presentation does not reflect the underlying inflammatory response. In accordance, differences in disease severity involve qualitatively and quantitatively different inflammatory responses. Nowadays, the challenge focuses on the necessity of designing innovative non-invasive chair-side point-of-care assessment methods, accounting for the biological profile as a complement to the existing clinical-radiographic assessment to contribute to the early evaluation of treatment outcome.
Rationale for conducting the research:
When dental pulp is infected or inflamed, various inflammatory mediators, including cytokines, chemokines, and neuropeptides, are released by innate and adaptive immune cells. During the development of pulp inflammation, inflammatory mediators result in the formation of apical osteolytic lesions. Bone loss is mainly caused by activated osteoclasts. Various cytokines such as interleukin (IL)-1, IL-11, IL-17, and tumor necrosis factor alpha (TNF-a) stimulate osteoclast progenitor cell differentiation and activation by the osteoprotegerin (OPG)/nuclear factor kappa B ligand (RANKL)/nuclear factor kappa B (RANK) complex.
The molecular mechanisms underlying bone resorption are regulated by the interaction between RANKL and OPG.The interaction between RANKL and RANK is necessary for the differentiation and activation of osteoclasts. This is modulated by OPG, which, in turn, suppresses osteoclast differentiation by preventing the interaction between RANKL and RANK.The production of OPG and RANKL by different cell types is regulated by local and systemic stimuli, including bacterial products, hormones, and inflammatory mediators.Changes in the balance of the mediators determine the progression and severity of bone diseases such as those found in periapical and periodontal lesions.
It has been reported that antibiotics regulate the immune response through modulation of cytokines production. Therefore, the level of cytokines, RANKL, and OPG can also be affected by antibiotics. In the infected root canal system, virulence products, antigens, and microbial cells are the main causes of apical periodontitis. Microorganisms in the root canal system adhere to root canal walls, isthmuses, ledges and commonly formed biofilm communities.The application of antimicrobial intra-canal medication is recommended to eliminate bacteria that could not be removed from the root canal system after instrumentation and irrigation of the root canals.
Calcium hydroxide (Ca (OH)2) is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. Because of its solubility, Ca (OH)2 releases calcium and hydroxyl ions slowly providing an alkaline environment in the periapical region.
There has been only a single in vivo study performed to evaluate the effect of Ca (OH)2 combined with ciprofloxacin or ibuprofen on the release of RANKL/OPG in periapical lesions. The aim of the present study is to evaluate the effect of double antibiotic paste when compared to Ca (OH)2, in terms of RANKL and OPG levels in chronic periapical lesions and correlate the results with periapical bone healing findings after a follow up period of one year.
- Conditions
- Biological Markers
- Being tested
- Double Antibiotic paste, Calcium Hydroxide Paste - Non-Setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Antibiotic pasteDrug
Also called Bimix
Metronidazole and Ciprofloxacin
Calcium Hydroxide Paste - Non-SettingDrug
Also called Metapaste
Calcium hydroxide paste to be delivered inside the canal as an intra-canal medication
| Study group | Role | What they receive |
|---|---|---|
| Double antibiotic paste intra-canal medication group (n=25) | Experimental | 500 mg Metronidazole tablet+ 500 mg Ciprofloxacin tablet crushed into powder and mixed together with salline to form a creamy mix to be placed inside the root canal for 1 week. Receives: Drug: Double Antibiotic paste |
| Calcium hydroxide intra-canal medication group (n=25) | Active comparator | Calcium hydroxide paste (Metapaste) placed inside the root canal for 1 week Receives: Drug: Calcium Hydroxide Paste - Non-Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of RANKL/OPG levels
RANKL/OPG levels will be measured post-instrumentation and 1 week postoperatively, using Absorbance using ELISA test, to calculate the percentage change of RANKL/OPG levels
Measured: measured Immediately post-instrumentation and after one week
Secondary outcomes (1)
Periapical healing
Periapical healing will be evaluated using CBCT (The lesion size is given a score according to the CBCT periapical index proposed by Estrela
Measured: CBCT scans will be done preoperatively and 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological MarkersStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Amr Saad Mohamed Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593238
- Sponsor's protocol ID
- ENDO: 3-3-6
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Double Antibiotic Paste Versus Calcium Hydroxide as Intra-canal Medications on RANKL/OPG Levels and Periapical Bone Healing in Patients With Asymptomatic Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04593238
- Acronym / sponsor ID
- ENDO: 3-3-6
- Conditions
- Biological Markers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 19 Oct 2020 (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.
The aim of the present study is to evaluate the effect of double antibiotic paste when compared to Ca (OH)2, in terms of RANKL and OPG levels in chronic periapical lesions and correlate the results with periapical bone healing findings after a follow up period of one year.
Detailed description
Apical periodontitis is an inflammatory disease that occurs as a consequence of the bacterial infection of dental pulp tissue. It represents an inflammatory/immune pathogenesis affecting the periapical tissue including the surrounding bone. This periapical process is primarily initiated by bacterial infection in the necrotic pulp. Its persistence, progression to chronic lesions and destruction of bone structures are a consequence of the inability of host-defense mechanisms to eradicate infection. Periapical lesions are characterized histologically by fibrous and granulated tissue, infiltrated by different inflammatory cells.
Up to now the diagnosis and follow-up of asymptomatic apical periodontitis AAP is based on a clinical radiographic evaluation, however, this reflects the accumulated damage from previous episodes of periodontal tissue destruction. Moreover, the clinical presentation does not reflect the underlying inflammatory response. In accordance, differences in disease severity involve qualitatively and quantitatively different inflammatory responses. Nowadays, the challenge focuses on the necessity of designing innovative non-invasive chair-side point-of-care assessment methods, accounting for the biological profile as a complement to the existing clinical-radiographic assessment to contribute to the early evaluation of treatment outcome.
Rationale for conducting the research:
When dental pulp is infected or inflamed, various inflammatory mediators, including cytokines, chemokines, and neuropeptides, are released by innate and adaptive immune cells. During the development of pulp inflammation, inflammatory mediators result in the formation of apical osteolytic lesions. Bone loss is mainly caused by activated osteoclasts. Various cytokines such as interleukin (IL)-1, IL-11, IL-17, and tumor necrosis factor alpha (TNF-a) stimulate osteoclast progenitor cell differentiation and activation by the osteoprotegerin (OPG)/nuclear factor kappa B ligand (RANKL)/nuclear factor kappa B (RANK) complex.
The molecular mechanisms underlying bone resorption are regulated by the interaction between RANKL and OPG.The interaction between RANKL and RANK is necessary for the differentiation and activation of osteoclasts. This is modulated by OPG, which, in turn, suppresses osteoclast differentiation by preventing the interaction between RANKL and RANK.The production of OPG and RANKL by different cell types is regulated by local and systemic stimuli, including bacterial products, hormones, and inflammatory mediators.Changes in the balance of the mediators determine the progression and severity of bone diseases such as those found in periapical and periodontal lesions.
It has been reported that antibiotics regulate the immune response through modulation of cytokines production. Therefore, the level of cytokines, RANKL, and OPG can also be affected by antibiotics. In the infected root canal system, virulence products, antigens, and microbial cells are the main causes of apical periodontitis. Microorganisms in the root canal system adhere to root canal walls, isthmuses, ledges and commonly formed biofilm communities.The application of antimicrobial intra-canal medication is recommended to eliminate bacteria that could not be removed from the root canal system after instrumentation and irrigation of the root canals.
Calcium hydroxide (Ca (OH)2) is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. Because of its solubility, Ca (OH)2 releases calcium and hydroxyl ions slowly providing an alkaline environment in the periapical region.
There has been only a single in vivo study performed to evaluate the effect of Ca (OH)2 combined with ciprofloxacin or ibuprofen on the release of RANKL/OPG in periapical lesions. The aim of the present study is to evaluate the effect of double antibiotic paste when compared to Ca (OH)2, in terms of RANKL and OPG levels in chronic periapical lesions and correlate the results with periapical bone healing findings after a follow up period of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double antibiotic paste intra-canal medication group (n=25) | Experimental | Drug: Double Antibiotic paste500 mg Metronidazole tablet+ 500 mg Ciprofloxacin tablet crushed into powder and mixed together with salline to form a creamy mix to be placed inside the root canal for 1 week. |
| Calcium hydroxide intra-canal medication group (n=25) | Active comparator | Drug: Calcium Hydroxide Paste - Non-SettingCalcium hydroxide paste (Metapaste) placed inside the root canal for 1 week |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients who are free from any physical or mental handicapping conditions and with no underlying systemic diseases.
- Age between 20-45years old.
- Males \& Females.
- Single canaled teeth:
- Patients who didn't use any NSAIDs or antibiotics for 1 month before treatment.
Key exclusion criteria (10 listed)
- - Medically compromised patients.
- Pregnant women.
- Patients reporting bruxism or clenching.
- Patients allergic to ciprofloxacin or metronidazole.
- Teeth associated with acute periapical abscess and/or swelling.
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 |
|---|---|---|
| Double Antibiotic pasteAlso: BimixMetronidazole and Ciprofloxacin | Drug | Double antibiotic paste intra-canal medication group (n=25) |
| Calcium Hydroxide Paste - Non-SettingAlso: MetapasteCalcium hydroxide paste to be delivered inside the canal as an intra-canal medication | Drug | Calcium hydroxide intra-canal medication group (n=25) |
Primary outcome
Percentage change of RANKL/OPG levels
Time frame: measured Immediately post-instrumentation and after one week
RANKL/OPG levels will be measured post-instrumentation and 1 week postoperatively, using Absorbance using ELISA test, to calculate the percentage change of RANKL/OPG levels
1 secondary outcome
Periapical healing
Time frame: CBCT scans will be done preoperatively and 6 and 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Double Antibiotic paste and Calcium Hydroxide Paste - Non-Setting in people with Biological Markers, 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 9 inclusion and 10 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 19 Oct 2020. 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. 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?
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?
Percentage change of RANKL/OPG levels (time frame: measured Immediately post-instrumentation and after one week). 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 19 Oct 2020.