Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars

Study Overview
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Brief Summary
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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
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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. Hyaluronic acid gel, which is a new product as a pulpotomy material, has been used in dentistry as well as medicine for many years. It is distributed widely in epithelial and connective tissues. Medical uses include joint treatments, skin lotions for atopic dermatitis, cosmetic surgery etc. In dentistry, gingivitis, teething, dental surgery including implants and sinus lifting procedures and oral ulcers are main target for hyaluronic acid treatment. This study extends the use of hyaluronic acid to primary tooth endodontics. 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. Sample size calculation showed that at first 40 teeth in each group will be required to detect a significant difference (80% power, two-sided 5% significance level). Ethical approval of the study was taken from the Clinical Research Ethics Committee, Faculty of Dentistry at Marmara University (No: 2019/288) in accordance with the Declaration of Helsinki. The patients' family will be given information about the pros and cons of the study on the relevant teeth and then a written consent will be obtained. Patients will be selected for this study according to the following criteria: Children who have good cooperation, do not require general anesthesia or sedation, and who do not have any systemic disease, allergic reactions, or any use of medications. No spontaneous, continuous pain in the tooth, no pathological or physiological mobility, no abscess and/or fistula, no tenderness to palpation or percussion. The tooth can be restored with a stainless steel crown (SSC) or a composite filling material after treatment. The physiological resorption in the tooth root not exceeding 1/3. No pathological resorption in the tooth root canals internally and/or externally, no radiolucency in the periapical or furcation regions, no enlargement of periodontal ligaments. Exclusion criteria: Children who have any disorders, spontaneous pain, no restorable primary molars, may exfoliate soon and teeth with apical periodontitis, pulp necrosis, abscess, fistula, swelling or mobility. Families who are not willing to join the study. After proper diagnosis of coronal pulpitis, local anesthesia is administrated, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol pulpotomy treatments, 40 primary molars for ferric sulfate treatments and 40 primary molars for 0.5% hyaluronic acid gel pulpotomy treatments. The tooth decay is removed, the roof of the pulp chamber is removed by joining the pulp horns with a bur cut. The coronal pulp is amputated from the chamber of the pulp with a sharp excavator and one or more cotton pellets is placed over the site and pressure is applied. When the hemostasis is insured, one of the medicament is applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide eugenol cement. The primary molars were restored either with a stainless-steel crown in case of proximal cavities or with a composite filling material in case of occlusal cavities. A single pediatric dentist will perform whole pulpotomy treatments and restorations of all selected teeth. The teeth will be followed clinically and radiographically at 1, 3, 6, 12 months. The teeth will be evaluated clinically and radiographically according to the following criteria: Clinical criteria: Spontaneous pain, tenderness to percussion and/or palpation, pathological mobility and abscess or fistula. Radiographic criteria: Periapical or furcal radiolucency, internal or external root resorption, loss of lamina dura. All evaluations will be performed by two calibrated pediatric dentists. The performing dentist will not be blinded to the treatment materials but the patient and two examiners who evaluated clinical and radiographic findings will be blinded to the treatment.

Official Title
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Clinical and Radiographic Evaluation of Formocresol, Ferric Sulfate and Hyaluronic Acid Pulpotomies on Human Primary Teeth: A Randomized Controlled Clinical Trial

Conditions
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Pulpitis

Intervention / Treatment
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* Procedure: Hyaluronic acid: Gengigel teething
* Procedure: Formocresol Buckley formula: Formacresol
* Procedure: Ferric sulfate: ViscoStat


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid<br>Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar. | Procedure: Hyaluronic acid: Gengigel teething<br>* Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.<br>|
| Active Comparator: Formocresol<br>0,1 ml to the orifice of the root canals of the primary molar. | Procedure: Formocresol Buckley formula: Formacresol<br>* Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.<br>|
| Active Comparator: Ferric sulfate<br>0,1 ml to the orifice of the root canals of the primary molar. | Procedure: Ferric sulfate: ViscoStat<br>* Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 1 month in 3 groups | 
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 3 months in 3 groups | 
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 6 months in 3 groups | 
| Number of Teeth Sensitive to Percussion in 3 Groups | Sensitivity to biting, chewing and clinically to the percussion by a probe | Change from Baseline at 12 months in 3 groups | 
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 1 month in 3 groups | 
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 3 month in 3 groups | 
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 6 month in 3 groups | 
| Number of Mobile Teeth in 3 Groups | Mobility of the treated tooth and/or the tooth is sensitive to the vibration | Change from Baseline at 12 months in 3 groups | 
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 1 month in 3 groups | 
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 3 months in 3 groups | 
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 6 months in 3 groups | 
| Number of Teeth With Patient Discomfort and/or Pain in 3 Groups | Any pain history at that time frame and/or complaint of discomfort and pain clinically | Change from Baseline at 12 months in 3 groups | 
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 1 month in 3 groups | 
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 3 months in 3 groups | 
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 6 months in 3 groups | 
| Number of Teeth With Dental Abscess in 3 Groups | Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically | Change from Baseline at 12 months | 
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 1 month in 3 groups | 
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 3 months in 3 groups | 
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 6 months in 3 groups | 
| Number of the Pathological Exfoliation of Affected Teeth in 3 Groups | The tooth is missing or ready to exfoliate physiologically and no pathology is examined | Change from Baseline at 12 months in 3 groups | 
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 1 month in 3 groups | 
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 3 months in 3 groups | 
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 6 months | 
| Number of Teeth With Root Resorption in 3 Groups | Internal, external, early or physiological root resorption from periapical/panoramic radiographs | Change from Baseline at 12 months | 
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 1 month in 3 groups | 
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 3 months in 3 groups | 
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 6 months in 3 groups | 
| Number of Teeth With Any Root Lesion From Radiography in 3 Groups | Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration | Change from Baseline at 12 months in 3 groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Change from Baseline at 1 month | 
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Change from Baseline at 3 months | 
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Change from Baseline at 6 months | 
| Restoration Stability | The survival rate of stainless steel crown and composite applied to each pulpotomized tooth | Change from Baseline at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpotomy