MucositisPhase 2NCT01737307
Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy
A Phase 2 study testing Fluoride varnish, Oral Hygiene and CPP-ACP in people with Mucositis and Dry Mouth, run by Azad University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study was to investigate the effect of Fluoride varnish and Casein Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and salivary characteristics in patients under chemotherapy. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- What is being tested?
- Fluoride varnish, Oral Hygiene and CPP-ACP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 2
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- to have cancer (in the first stage of their treatments)
- to have at least 20 teeth,
- age over 12
Who cannot join
- to have pathologic lesion in the oral cavity
- being under radiotherapy
- to have specific systemic diseases
- to have head and neck cancer
Trial locations and contacts
1 site in 1 country.
Iran1 site
Azad University of Medical Sciences, Dental Branch
Tehran, Tehran Province
About this study
Official title: Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial
The purpose of this study was to investigate the effect of Fluoride varnish and Casein Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and salivary characteristics in patients under chemotherapy.
Read the detailed description
Chemotherapy as a treatment method of cancers, affects different parts of the oral cavity such as oral mucosa, teeth and salivary glands caused by salivary glands dysfunction during chemotherapy.Oral status of patients under chemotherapy will be affected by consumption of the drugs and their side effects such as reduction of the saliva, dryness of the oral cavity, changes in bacterial balance, oral mucosa damage, bleeding due to irritation of the tissues, xerostomia, dental caries, burning sensation, dysgeusia and dysphagia. No effective preventive protocol has been presented for oral care during chemotherapy.
Patients who were met the inclusion criteria (aged over 12, diagnosed to have cancer by an oncologists and needed chemotherapy drugs, had at least 20 teeth, had no other pathologic lesion in their oral cavity, were not treated by radiotherapy and did not have specific systemic diseases or head and neck cancer) were selected for the study. the participants were evaluated according to oral and salivary symptoms.
- Being tested
- Fluoride varnish, Oral Hygiene, CPP-ACP
- Keywords
- Fluoride Varnish, CPP-ACP paste, Dry mouth, Burning sensation, Chemotherapy
- Medical subject headings
- Mucositis, Xerostomia, Infections, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishDrug
Also called Fluoride varnish(NaF 5%,Sultan,USA)
Fluoride Varnish (NaF 5%)
Oral HygieneOther
Also called Twice daily (tooth brush and tooth paste).
Oral hygiene followed.
CPP-ACPDrug
Also called CPP-ACP Paste was used in this group., 3 gr , once daily , 42 days.
CPP-ACP paste was applied by patient, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish | Experimental | Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA) Receives: Drug: Fluoride varnish |
| Oral hygiene | Experimental | Oral hygiene followed twice daily. No F varnish or CPP-ACP applied. Receives: Other: Oral Hygiene |
| CPP-ACP | Experimental | CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days. Receives: Drug: CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
Measured: 6 weeks after first visit
Secondary outcomes (4)
pH of saliva
Measured: 6 weeks after first visit
pH of dental plaque
Measured: 6 weeks after first visit
Quantity of saliva ( rest and stimulated)
Measured: 6 weeks after first visit
Saliva buffering capacity
Measured: 6 weeks after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sepideh Banava.DDS,MS, Azad University of Medical Sciences
- Investigators
- Sepideh Banava, Assist-Prof, Principal investigator, Azad University of Medical Sciences, Dental Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737307
- Sponsor's protocol ID
- AZadUMS
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01737307
- Acronym / sponsor ID
- AZadUMS
- Keywords
- Fluoride Varnish, CPP-ACP paste, Dry mouth, Burning sensation, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azad University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Nov 2012 (estimated)
- 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 purpose of this study was to investigate the effect of Fluoride varnish and Casein Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and salivary characteristics in patients under chemotherapy.
Detailed description
Chemotherapy as a treatment method of cancers, affects different parts of the oral cavity such as oral mucosa, teeth and salivary glands caused by salivary glands dysfunction during chemotherapy.Oral status of patients under chemotherapy will be affected by consumption of the drugs and their side effects such as reduction of the saliva, dryness of the oral cavity, changes in bacterial balance, oral mucosa damage, bleeding due to irritation of the tissues, xerostomia, dental caries, burning sensation, dysgeusia and dysphagia. No effective preventive protocol has been presented for oral care during chemotherapy.
Patients who were met the inclusion criteria (aged over 12, diagnosed to have cancer by an oncologists and needed chemotherapy drugs, had at least 20 teeth, had no other pathologic lesion in their oral cavity, were not treated by radiotherapy and did not have specific systemic diseases or head and neck cancer) were selected for the study. the participants were evaluated according to oral and salivary symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish | Experimental | Drug: Fluoride varnishFluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA) |
| Oral hygiene | Experimental | Other: Oral HygieneOral hygiene followed twice daily. No F varnish or CPP-ACP applied. |
| CPP-ACP | Experimental | Drug: CPP-ACPCPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- to have cancer (in the first stage of their treatments)
- to have at least 20 teeth,
- age over 12
Key exclusion criteria (4 listed)
- to have pathologic lesion in the oral cavity
- being under radiotherapy
- to have specific systemic diseases
- to have head and neck cancer
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 |
|---|---|---|
| Fluoride varnishAlso: Fluoride varnish(NaF 5%,Sultan,USA)Fluoride Varnish (NaF 5%) | Drug | Fluoride Varnish |
| Oral HygieneAlso: Twice daily (tooth brush and tooth paste).Oral hygiene followed. | Other | Oral hygiene |
| CPP-ACPAlso: CPP-ACP Paste was used in this group., 3 gr , once daily , 42 days.CPP-ACP paste was applied by patient, once daily. | Drug | CPP-ACP |
Primary outcome
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.
Time frame: 6 weeks after first visit
4 secondary outcomes
pH of saliva
Time frame: 6 weeks after first visit
pH of dental plaque
Time frame: 6 weeks after first visit
Quantity of saliva ( rest and stimulated)
Time frame: 6 weeks after first visit
Saliva buffering capacity
Time frame: 6 weeks after first visit
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 29 Nov 2012.
Related trials for Mucositis
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
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.
Sepideh Banava, Assist-Prof principal investigator
Azad University of Medical Sciences, Dental Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoride varnish, Oral Hygiene and CPP-ACP in people with Mucositis and Dry Mouth, run by Azad University of Medical Sciences at 1 site in Iran.
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 3 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 29 Nov 2012. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth. (time frame: 6 weeks after first visit). 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 29 Nov 2012.