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Effect of Photodynamic Therapy on Deep Caries in Permanent Tooth,A Controlled Clinical Trial

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ClinicalTrials.gov Identifier: NCT02929914
Recruitment Status : Unknown
Verified October 2016 by Xiaojing Huang, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : October 11, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaojing Huang, Fujian Medical University

Brief Summary:
The aim of the proposed study is to assess the clinical effect of photodynamic therapy (PDT)using LED on dentin with carious lesions in permanent teeth. Patients with molars exhibiting deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to two groups: Group 1 -Control after incomplete caries removal,indirect pulp treatment with calcium hydroxide(CH); Group 2 - PDT + CH after incomplete caries removal,disinfect the residual dentin with PDT(LED + methylene),then indirect pulp treatment with CH. Dentin samples will be removed before and after PDT for microbiological analysis. The microbiological samples will be cultured in Brucella blood agar, Mitis Salivarius-bacitracin agar and Rogosa Selective Lactobacillus agar. The teeth will then be restored using resin with clinical and radiographic follow up at six, 12 and 24 months. The data will be submitted to descriptive statistics.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Rubber dam isolation Procedure: Tooth drying Procedure: Dentin wash with sodium 0.9% saline Procedure: Antimicrobial Photodynamic Therapy Drug: sodium 0.9% saline Device: DENFOTEX PADplus Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Photodynamic Therapy on Deep Caries in Permanent Tooth,A Controlled Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Control
Rubber dam isolation,tooth drying,remove caries incompletely,microbiological sample with otoscope curette,dentin wash with sodium 0.9% saline,sampling again.Indirect pulp treatment with calcium hydroxide(CH).Restoration with resin(Z350,3M);Follow up at 6,12 and 24 months.
Procedure: Rubber dam isolation
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples

Procedure: Tooth drying
The tooth was dried with air jet.

Procedure: Dentin wash with sodium 0.9% saline
Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed. The remaining dentin was washed with sodium 0.9% saline. After that a a new dentin collection was performed at another site of the cavity, and teeth were conventionally restored using the following materials: calcium hydroxide lining material and resin(Z350,3M)

Drug: sodium 0.9% saline
Dentin is washed with sodium 0.9% saline.

Experimental: PDT+CH
Rubber dam isolation,tooth drying,remove caries incompletely,microbiological sample with otoscope curette,disinfect the remaining dentin with antimicrobial photodynamic therapy(DENFOTEX PADplus),sampling again.Indirect pulp treatment with calcium hydroxide(CH).Restoration with resin(Z350,3M);Follow up at 6,12 and 24 months.
Procedure: Rubber dam isolation
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples

Procedure: Tooth drying
The tooth was dried with air jet.

Procedure: Antimicrobial Photodynamic Therapy
Partial carious tissue was removed with conventional dentine curette and collection of dentin with a spoon (1#) was performed. The remaining dentin was washed with 200 µL of O-Toluidine blue dye (0.1 mg/mL) for 60 s. After this, a red LED light source with wavelength of 630 nm was used at 100 mW(medium Wave) power, 9.0 J of energy, for 60 s with energy density of 30.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity.Then teeth were conventionally restored using the following materials: calcium hydroxide lining material and resin(Z350,3M)

Device: DENFOTEX PADplus
Dentin is disinfected by using DENFOTEX PADplus.




Primary Outcome Measures :
  1. Quantification of Bacteria by colony counting [ Time Frame: 2 days after dentin collection ]
    Quantification of S. mutans, L. casei and total bacteria


Secondary Outcome Measures :
  1. Tooth Pain [ Time Frame: 6 months ]
    Patients reported the presence or absence of tooth pain after 6 months

  2. Tooth Pain [ Time Frame: 12 months ]
    Patients reported the presence or absence of tooth pain after 12 months

  3. Restoration Quality [ Time Frame: 6 months ]
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months

  4. Restoration Quality [ Time Frame: 12 months ]
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months



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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits.

Exclusion Criteria:

  • People who refused to sign the informed consent document,who was allergic to photosensitizer, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929914


Contacts
Contact: Minjing Wu, bachelor +8618050194716 837427505@qq.com

Locations
China, Fujian
School and Hospital of Stomatology,Fujian Medical University Recruiting
Fuzhou, Fujian, China
Contact: Mijing Wu, bachelor    +8618050194716    837427505@qq.com   
Sponsors and Collaborators
Fujian Medical University
Investigators
Study Chair: Xiaojing Huang, PhD School and Hospital of stomatology,Fujian Medical University

Responsible Party: Xiaojing Huang, DDS, PhD, Professor,Vice Dean,School and Hospital of Stomatology Fujian Medical University, Fujian Medical University
ClinicalTrials.gov Identifier: NCT02929914     History of Changes
Other Study ID Numbers: PDT20160602
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xiaojing Huang, Fujian Medical University:
Carious dentin
Photodynamic Therapy

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Anti-Infective Agents
Anti-Bacterial Agents
Bone Density Conservation Agents
Physiological Effects of Drugs