Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy

NCT01737307 | Completed Phase 2 DMC

• 1 other identifier: AZadUMS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mucositis; Dry Mouth; Infection

Keywords

Fluoride Varnish; CPP-ACP paste; Dry mouth; Burning sensation; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• oral symptoms(mucositis, xerostomia, infection, dysphagia, dysgeusia, burning sensation in mouth.

  6 weeks after first visit

Secondary Outcomes (4)

• pH of saliva

  6 weeks after first visit

• pH of dental plaque

  6 weeks after first visit

• Quantity of saliva ( rest and stimulated)

  6 weeks after first visit

• Saliva buffering capacity

  6 weeks after first visit

Study Arms (3)

Fluoride Varnish

EXPERIMENTAL

Fluoride varnish was used once in this group. Fluoride varnish(NaF 5%,Sultan,USA)

Drug: Fluoride varnish

Oral hygiene

EXPERIMENTAL

Oral hygiene followed twice daily. No F varnish or CPP-ACP applied.

Other: Oral Hygiene

CPP-ACP

EXPERIMENTAL

CPP-ACP paste (GC Tooth Mousse,Gc,USA)was applied by patients once daily. 3gr,for 42 days.

Drug: CPP-ACP

Interventions

Fluoride varnish DRUG

Fluoride Varnish (NaF 5%)

Also known as: Fluoride varnish(NaF 5%,Sultan,USA)

Fluoride Varnish

Oral Hygiene OTHER

Oral hygiene followed.

Also known as: Twice daily (tooth brush and tooth paste).

Oral hygiene

CPP-ACP DRUG

CPP-ACP paste was applied by patient, once daily.

Also known as: CPP-ACP Paste was used in this group., 3 gr , once daily , 42 days.

CPP-ACP

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to have cancer (in the first stage of their treatments)
• to have at least 20 teeth,
• age over 12

You may not qualify if:

• to have pathologic lesion in the oral cavity
• being under radiotherapy
• to have specific systemic diseases
• to have head and neck cancer

Sponsors & Collaborators

• Azad University of Medical Sciences: lead

Study Sites (1)

Azad University of Medical Sciences, Dental Branch

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Mucositis; Xerostomia; Infections; Paresthesia

Interventions

Oral Hygiene; Toothbrushing; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics; Preventive Dentistry; Dentistry

Study Officials

• Sepideh Banava, Assist-Prof

  Azad University of Medical Sciences, Dental Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Of Restorative Department

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 29, 2012
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

IR (1)