Periodontitis Stage IEarly Phase 1NCT05435378
Effect of Adjunctive Use of Vitamin B3 and B9 on Myeloperoxidase Level in the GCF of Patients With Stage I and II Periodontitis
A Early Phase 1 study testing Vitamin B3 100 MG Oral Tablet, vitamin B9 and full mouth non surgical periodontal treatment in people with Periodontitis Stage I and Periodontal Diseases, run by Cairo University.
Trial summary
this study addresses the effect of the vitamin B3 and vitamin B9 on the periodontal healing at the sites of periodontal destruction due to periodontitis and evaluate its added effect to the conventional non-surgical periodontal treatment on its pivotal role in the biological activities and repair in the body in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontitis Stage I, Periodontal Diseases, Periodontal Inflammation
- What is being tested?
- Vitamin B3 100 MG Oral Tablet, vitamin B9 and full mouth non surgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Dec 2022
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with gingivitis or stage I/II periodontits. The presence of gingivitis and the presence/severity of periodontitis is registered using the American Academy of Periodontology 2017 workshop published definition With this method, patient was identified affected by periodontits when ''Interdental CAL is detectable at ≥2 non-adjacent teeth, or Buccal/oral CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth'' (Toentti et al, 2018) with grade I severity being cases with interdental CAL from 1-2mm and grade II severity being cases with interdental CAL from 3-4 mm
Who cannot join
- Patients incapable of giving informed consent
- Patients unable to attend the 3-month follow-up
- Patients with interdental CAL >4mm
- Patient requiring surgical periodontal treatment
- Patients on systemically administered vitamin B or vitamin B-complex
- Patients undergoing chemo- or immunosuppressive therapy over the previous 5 years
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- Patients treated or undergoing treatment with intravenous amino-bisphosphonates
- Patients with poor oral motivation
- Substance abusers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Adjunctive Use of Vitamin B3 and B9 on Myeloperoxidase Level in the GCF of Patients With Stage I and II Periodontitis, a Randomized, Parallel Group, Double Blinded, Placebo Controlled Study
this study addresses the effect of the vitamin B3 and vitamin B9 on the periodontal healing at the sites of periodontal destruction due to periodontitis and evaluate its added effect to the conventional non-surgical periodontal treatment on its pivotal role in the biological activities and repair in the body in general and the periodontium in specific. The research will be conducted on patients suffering from stage I and II periodontitis that typically are to be treated with non surgical periodontal therapy, the rationale of the non surgical periodontal treatment is eliminating the plaque biofilm responsible for stimulation of host immune defense causing the inflammation and hence suppressing the periodontal destruction.
the trial is targeting enhancing the treatment effect by the administration of vitamin B3 and B9 supplements which will target the host inflammatory reaction itself and directly suppressing it as well as enhancing the periodontal regeneration and the gain of the lost attachment.
Read the detailed description
This study is a parallel group randomized, Double-blinded, Placebo-controlled clinical trial The follow up of this study is set to be in a three months interval in order to monitor the effect of the periodontal treatment with/without vitamin B-3 and B-9 supplement on the periodontal repair and regeneration
The eligible patients will be randomized into three groups with four interventions:
- Non-surgical scaling and debridement with placebo
- Non-surgical scaling and debridement with vitamin B-3
- Non-surgical scaling and debridement with vitamin B-9 Before intervention, a gingival cervicular fluid sample will be collected for all groups to measure the myeloperoxidase level at baseline before treatment then a full mouth scaling and debridement will be done by the primary investigator using ultrasonic scaler and periodontal curettes. After the non surgical treatment patients will be given oral hygiene instructions where they will be instructed to brush twice daily and shown how to brush using the horizontal scraping technique they will also be instructed to use the dental floss and shown how to use it. The systemically administered vitamin B or placebo capsules will then given to the patients and instructed to be taken once daily for 30 days. Patients are instructed not to take any vitamin B supplementations during the period of treatment, patients are also instructed to discontinue using the drug if any allergic reaction appeared and directly report it to the investigator.
Periodontal maintenance appointments which will include a review of medical and dental histories, supra- and subgingival instrumentation if needed, and oral hygiene instructions and motivation will be performed at 14, 30, 60 and 90 days.
- Conditions
- Periodontitis Stage I, Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss, Periodontitis, Periodontitis Stage II
- Being tested
- Vitamin B3 100 MG Oral Tablet, vitamin B9, Placebo, full mouth non surgical periodontal treatment
- Medical subject headings
- Periodontitis, Periodontal Diseases, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B3 100 MG Oral TabletDrug
Also called niacin, niacinamide, nicotinamide
After the non surgical treatment and the oral hygiene instructions The systemically administered vitamin B3 capsules will then given to the patients under the previously mentioned dosage.
vitamin B9Drug
Also called Folic acid, Folate, folacin
After the non surgical treatment and the oral hygiene instructions the systemically administered vitamin B9 capsules will then given to the patients under the previously mentioned dosage.
PlaceboDrug
Also called inactive drug
After the non surgical treatment and the oral hygiene instructions The systemically administered placebo capsules will then given to the patients under the previously mentioned dosage.
full mouth non surgical periodontal treatmentProcedure or surgery
full mouth scaling and debridement will be done by the primary investigator using ultrasonic scaler and periodontal curettes. After the non surgical treatment patients will be given oral hygiene instructions where they will be instructed to brush twice daily and shown how to brush using the horizontal scraping technique they will also be instructed to use the dental floss and shown how to use it.
| Study group | Role | What they receive |
|---|---|---|
| vitamin B3 | Experimental | Vitamin B-3 capsule consists of Manufacturer: DSM Nutritional products Ltd generic name: nicotine amide Constituent components: 100mg of nicotine amide Route of administration: orally dosing schedule:1capsule/day/ before meal duration: for 30 days Receives: Drug: Vitamin B3 100 MG Oral Tablet; Procedure: full mouth non surgical periodontal treatment |
| Vitamin B-9 | Experimental | Vitamin B-9 capsule Manufacturer: Hebei Jiheng pharmaceutical Co. Ltd generic name: folic acid. Constituent components: 5 mg of folic acid. Route of administration: orally dosing schedule: 1capsule/day/before meal duration: for 30 days Receives: Drug: vitamin B9; Procedure: full mouth non surgical periodontal treatment |
| Placebo capsule | Placebo comparator | Placebo capsule Manufacturer: Shivangan Foods \& Pharma Products Pvt. Ltd Constituent components: inactive fillers Route of administration: orally dosing schedule: 1capsule/day/before meal duration: for 30 days Receives: Drug: Placebo; Procedure: full mouth non surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change form the baseline in myeloperoxidase level in gingival crevicular fluid at 90 days
biological sample of GCF will be collected and the enzyme level in GCF will be measured using The enzyme-linked immunosorbent assay (ELISA)
Measured: baseline and 90 days
change form the baseline in clinical attachment level at 90 days
Using a University of North Carolina probe (UNC) -15 measuring the distance from the cement-enamel junction to the base of the periodontal pocket at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual)
Measured: baseline and 90 days
Secondary outcomes (4)
change form the baseline in periodontal pocket depth at 90 days
Using UNC15 periodontal probe measuring the distance from the gingival margin to the base of the pocket at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual)
Measured: baseline and 90 days
change form the baseline in bleeding on probing at 90 days
Using UNC15 periodontal probe at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual) recorded at each site as present or absent
Measured: baseline and 90 days
change form the baseline in plaque index at 90 days
Manual UNC periodontal probe setting Scores of :
0: No plaque
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of a disclosing solution or by using the probe on the tooth surface.
- Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: parameter will be evaluated at baseline and at 90 days
Patient satsification
VAS for patient satisfaction a Scale from 1-10 0 (completely dissatisfied)to 10 (completely satisfied).
Measured: Parameter will be evaluated at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Stage IStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Essam Hussien Elkholy, Cairo University
- Investigators
- Riham Omar, professor, Study chair, main supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435378
- Sponsor's protocol ID
- PER 3.3.2
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjunctive Use of Vitamin B3 and B9 on Myeloperoxidase Level in the GCF of Patients With Stage I and II Periodontitis, a Randomized, Parallel Group, Double Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT05435378
- Acronym / sponsor ID
- PER 3.3.2
- Conditions
- Periodontitis Stage I, Periodontal Diseases, Periodontal Inflammation, Periodontal Attachment Loss, Periodontitis, Periodontitis Stage II
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Jun 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.
this study addresses the effect of the vitamin B3 and vitamin B9 on the periodontal healing at the sites of periodontal destruction due to periodontitis and evaluate its added effect to the conventional non-surgical periodontal treatment on its pivotal role in the biological activities and repair in the body in general and the periodontium in specific. The research will be conducted on patients suffering from stage I and II periodontitis that typically are to be treated with non surgical periodontal therapy, the rationale of the non surgical periodontal treatment is eliminating the plaque biofilm responsible for stimulation of host immune defense causing the inflammation and hence suppressing the periodontal destruction.
the trial is targeting enhancing the treatment effect by the administration of vitamin B3 and B9 supplements which will target the host inflammatory reaction itself and directly suppressing it as well as enhancing the periodontal regeneration and the gain of the lost attachment.
Detailed description
This study is a parallel group randomized, Double-blinded, Placebo-controlled clinical trial The follow up of this study is set to be in a three months interval in order to monitor the effect of the periodontal treatment with/without vitamin B-3 and B-9 supplement on the periodontal repair and regeneration
The eligible patients will be randomized into three groups with four interventions:
- Non-surgical scaling and debridement with placebo
- Non-surgical scaling and debridement with vitamin B-3
- Non-surgical scaling and debridement with vitamin B-9 Before intervention, a gingival cervicular fluid sample will be collected for all groups to measure the myeloperoxidase level at baseline before treatment then a full mouth scaling and debridement will be done by the primary investigator using ultrasonic scaler and periodontal curettes. After the non surgical treatment patients will be given oral hygiene instructions where they will be instructed to brush twice daily and shown how to brush using the horizontal scraping technique they will also be instructed to use the dental floss and shown how to use it. The systemically administered vitamin B or placebo capsules will then given to the patients and instructed to be taken once daily for 30 days. Patients are instructed not to take any vitamin B supplementations during the period of treatment, patients are also instructed to discontinue using the drug if any allergic reaction appeared and directly report it to the investigator.
Periodontal maintenance appointments which will include a review of medical and dental histories, supra- and subgingival instrumentation if needed, and oral hygiene instructions and motivation will be performed at 14, 30, 60 and 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin B3 | Experimental | Drug: Vitamin B3 100 MG Oral Tablet, Procedure: full mouth non surgical periodontal treatmentVitamin B-3 capsule consists of Manufacturer: DSM Nutritional products Ltd generic name: nicotine amide Constituent components: 100mg of nicotine amide Route of administration: orally dosing schedule:1capsule/day/ before meal duration: for 30 days |
| Vitamin B-9 | Experimental | Drug: vitamin B9, Procedure: full mouth non surgical periodontal treatmentVitamin B-9 capsule Manufacturer: Hebei Jiheng pharmaceutical Co. Ltd generic name: folic acid. Constituent components: 5 mg of folic acid. Route of administration: orally dosing schedule: 1capsule/day/before meal duration: for 30 days |
| Placebo capsule | Placebo comparator | Drug: Placebo, Procedure: full mouth non surgical periodontal treatmentPlacebo capsule Manufacturer: Shivangan Foods \& Pharma Products Pvt. Ltd Constituent components: inactive fillers Route of administration: orally dosing schedule: 1capsule/day/before meal duration: for 30 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with gingivitis or stage I/II periodontits. The presence of gingivitis and the presence/severity of periodontitis is registered using the American Academy of Periodontology 2017 workshop published definition With this method, patient was identified affected by periodontits when ''Interdental CAL is detectable at ≥2 non-adjacent teeth, or Buccal/oral CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth'' (Toentti et al, 2018) with grade I severity being cases with interdental CAL from 1-2mm and grade II severity being cases with interdental CAL from 3-4 mm
Key exclusion criteria (9 listed)
- Patients incapable of giving informed consent
- Patients unable to attend the 3-month follow-up
- Patients with interdental CAL >4mm
- Patient requiring surgical periodontal treatment
- Patients on systemically administered vitamin B or vitamin B-complex
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 |
|---|---|---|
| Vitamin B3 100 MG Oral TabletAlso: niacin, niacinamide, nicotinamideAfter the non surgical treatment and the oral hygiene instructions The systemically administered vitamin B3 capsules will then given to the patients under the previously mentioned dosage. | Drug | vitamin B3 |
| vitamin B9Also: Folic acid, Folate, folacinAfter the non surgical treatment and the oral hygiene instructions the systemically administered vitamin B9 capsules will then given to the patients under the previously mentioned dosage. | Drug | Vitamin B-9 |
| PlaceboAlso: inactive drugAfter the non surgical treatment and the oral hygiene instructions The systemically administered placebo capsules will then given to the patients under the previously mentioned dosage. | Drug | Placebo capsule |
| full mouth non surgical periodontal treatmentfull mouth scaling and debridement will be done by the primary investigator using ultrasonic scaler and periodontal curettes. After the non surgical treatment patients will be given oral hygiene instructions where they will be instructed to brush twice daily and shown how to brush using the horizontal scraping technique they will also be instructed to use the dental floss and shown how to use it. | Procedure or surgery | Placebo capsule, Vitamin B-9, vitamin B3 |
Primary outcome
change form the baseline in myeloperoxidase level in gingival crevicular fluid at 90 days
Time frame: baseline and 90 days
biological sample of GCF will be collected and the enzyme level in GCF will be measured using The enzyme-linked immunosorbent assay (ELISA)
change form the baseline in clinical attachment level at 90 days
Time frame: baseline and 90 days
Using a University of North Carolina probe (UNC) -15 measuring the distance from the cement-enamel junction to the base of the periodontal pocket at six sites of the tooth (mesiobuccal-distobucal-midbucal-mesiolingual-distolingual-midlingual)
4 secondary outcomes
change form the baseline in periodontal pocket depth at 90 days
Time frame: baseline and 90 days
change form the baseline in bleeding on probing at 90 days
Time frame: baseline and 90 days
change form the baseline in plaque index at 90 days
Time frame: parameter will be evaluated at baseline and at 90 days
Patient satsification
Time frame: Parameter will be evaluated at 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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Periimplantitis, Periodontitis
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Minimally Invasive Non-Surgical Periodontal Therapy Alone vs. Minimally Invasive Non-Surgical Periodontal Therapy With I-PRF With or Without Chlorhexidine on Stage III Periodontitis Patients
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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.
Riham Omar, professor study chair
main supervisor
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin B3 100 MG Oral Tablet, vitamin B9 and full mouth non surgical periodontal treatment in people with Periodontitis Stage I and Periodontal Diseases, 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 1 inclusion and 9 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elham Elkholy (+201111342530, elham.hussien@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change form the baseline in myeloperoxidase level in gingival crevicular fluid at 90 days (time frame: baseline and 90 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 28 Jun 2022.