Clinical and Radiographic Evaluation of Formocresol, Ferric Sulfate and Hyaluronic Acid Pulpotomies on Human Primary Teeth: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Marmara University
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Number of Teeth With Root Resorption in 3 Groups
Study Overview
Brief Summary
In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who apply to Marmara University Faculty of Dentistry, Department of Pediatric Dentistry will be subjected to pulpotomy treatments. After proper diagnosis of coronal pulpitis, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol (FC) pulpotomy treatments, 40 primary molars for ferric sulfate (FS) treatments and 40 primary molars for 0.5% hyaluronic acid gel (HA) pulpotomy treatments. The tooth decay will be removed, the pulp will be amputated from the chamber of the pulp with a sharp excavator and one of the medicament will be applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide cement, and the primary molars will be restored with a composite filling material or with a stainless steel crown (SSC). A single investigator will perform the procedure. The teeth will be followed clinically and radiographically at 1st, 3rd, 6th, 12th months.
Detailed Description
The aim of this study is to compare the efficacy of the materials used in pulpotomies, and to evaluate the success of hyaluronic gel over the formocresol and/or ferric sulfate considered as the gold standard for this type of treatment.
Pulpotomy is an endodontic treatment method aiming to maintain primary molar affected from deep caries and acute pulpitis by removing the effected pulpal tissue, leaving the remaining root canal pulp and maintaining its vitality and function until the tooth exfoliates physiologically. In order to remain canals intact and uninflamed various dental materials are used according to treatment purposes; categorized into three groups as devitalizing, preventive and regenerative treatment.
- Devitalization: Formocresol, Glutaraldehyde, Electro-surgery
- Protective: Ferric Sulfate, Calcium Hydroxide, Mineral Trioxide Aggregate, Lasers
- Regenerative: Bone Morphogenetic Protein, Enriched Collagen
The ideal agent or method for pulpotomy treatment of the primary teeth has not been determined yet but the earliest method of diluted formocresol is considered by many the gold standard. Formocresol is a strong strain that fixes living tissues. It contains formaldehyde gas, organic structures, dentin channels and narrow side channels until the bacteria are also fixed. 10% formalin solution (14% formaldehyde) is used as a tissue fixative.
Ferric Sulfate an other material for pulpotomy is used in dentistry mainly as a hemostatic agent. It has several advantages over formocresol such as non-mutagenic property and keeping root canal pulp vital.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •No systemic disease,
- •No pathological mobility and/or resorption of the tooth,
- •No pain and/or abscess,
- •Parents volunteering,
- •The patients are between 5-9 years old.
Exclusion Criteria
- •Systemic disease,
- •Pathological mobility and resorption of the tooth,
- •Pain and/or abscess,
- •Non voluntary,
- •The patients aren't between 5-9 years old.
Arms & Interventions
Hyaluronic acid
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar.
Intervention: Hyaluronic acid: Gengigel teething (Procedure)
Formocresol
0,1 ml to the orifice of the root canals of the primary molar.
Intervention: Formocresol Buckley formula: Formacresol (Procedure)
Ferric sulfate
0,1 ml to the orifice of the root canals of the primary molar.
Intervention: Ferric sulfate: ViscoStat (Procedure)
Outcomes
Primary Outcomes
Number of Teeth With Root Resorption in 3 Groups
Time Frame: Change from Baseline at 12 months
Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Time Frame: Change from Baseline at 12 months in 3 groups
The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Number of Teeth With Dental Abscess in 3 Groups
Time Frame: Change from Baseline at 12 months
Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Time Frame: Change from Baseline at 12 months in 3 groups
Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Number of Teeth Sensitive to Percussion in 3 Groups
Time Frame: Change from Baseline at 12 months in 3 groups
Sensitivity to biting, chewing and clinically to the percussion by a probe
Number of Mobile Teeth in 3 Groups
Time Frame: Change from Baseline at 12 months in 3 groups
Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Time Frame: Change from Baseline at 12 months in 3 groups
Any pain history at that time frame and/or complaint of discomfort and pain clinically
Number of Teeth Sensitive to Percussion in 3 Groups
Time Frame: Change from Baseline at 1 month in 3 groups
Sensitivity to biting, chewing and clinically to the percussion by a probe
Number of Teeth Sensitive to Percussion in 3 Groups
Time Frame: Change from Baseline at 3 months in 3 groups
Sensitivity to biting, chewing and clinically to the percussion by a probe
Number of Teeth Sensitive to Percussion in 3 Groups
Time Frame: Change from Baseline at 6 months in 3 groups
Sensitivity to biting, chewing and clinically to the percussion by a probe
Number of Mobile Teeth in 3 Groups
Time Frame: Change from Baseline at 1 month in 3 groups
Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Number of Mobile Teeth in 3 Groups
Time Frame: Change from Baseline at 3 month in 3 groups
Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Number of Mobile Teeth in 3 Groups
Time Frame: Change from Baseline at 6 month in 3 groups
Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Time Frame: Change from Baseline at 1 month in 3 groups
Any pain history at that time frame and/or complaint of discomfort and pain clinically
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Time Frame: Change from Baseline at 3 months in 3 groups
Any pain history at that time frame and/or complaint of discomfort and pain clinically
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Time Frame: Change from Baseline at 6 months in 3 groups
Any pain history at that time frame and/or complaint of discomfort and pain clinically
Number of Teeth With Dental Abscess in 3 Groups
Time Frame: Change from Baseline at 1 month in 3 groups
Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Number of Teeth With Dental Abscess in 3 Groups
Time Frame: Change from Baseline at 3 months in 3 groups
Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Number of Teeth With Dental Abscess in 3 Groups
Time Frame: Change from Baseline at 6 months in 3 groups
Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Time Frame: Change from Baseline at 1 month in 3 groups
The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Time Frame: Change from Baseline at 3 months in 3 groups
The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Time Frame: Change from Baseline at 6 months in 3 groups
The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Number of Teeth With Root Resorption in 3 Groups
Time Frame: Change from Baseline at 1 month in 3 groups
Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Number of Teeth With Root Resorption in 3 Groups
Time Frame: Change from Baseline at 3 months in 3 groups
Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Number of Teeth With Root Resorption in 3 Groups
Time Frame: Change from Baseline at 6 months
Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Time Frame: Change from Baseline at 1 month in 3 groups
Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Time Frame: Change from Baseline at 3 months in 3 groups
Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Time Frame: Change from Baseline at 6 months in 3 groups
Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Secondary Outcomes
- Restoration Stability(Change from Baseline at 12 months)
- Restoration Stability(Change from Baseline at 1 month)
- Restoration Stability(Change from Baseline at 3 months)
- Restoration Stability(Change from Baseline at 6 months)