Clinical trial NCT04115358: Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars
Official title: Clinical and Radiographic Evaluation of Formocresol, Ferric Sulfate and Hyaluronic Acid Pulpotomies on Human Primary Teeth: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis
Keywords: Pulpotomy
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 47
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

1. Devitalization: Formocresol, Glutaraldehyde, Electro-surgery
2. Protective: Ferric Sulfate, Calcium Hydroxide, Mineral Trioxide Aggregate, Lasers
3. 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:

1. 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.
2. No spontaneous, continuous pain in the tooth, no pathological or physiological mobility, no abscess and/or fistula, no tenderness to palpation or percussion.
3. The tooth can be restored with a stainless steel crown (SSC) or a composite filling material after treatment.
4. The physiological resorption in the tooth root not exceeding 1/3.
5. 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:

1. 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.
2. 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:

1. Clinical criteria: Spontaneous pain, tenderness to percussion and/or palpation, pathological mobility and abscess or fistula.
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Teeth Sensitive to Percussion in 3 Groups
timeFrame: Change from Baseline at 1 month in 3 groups
measure: Number of Teeth Sensitive to Percussion in 3 Groups
timeFrame: Change from Baseline at 3 months in 3 groups
measure: Number of Teeth Sensitive to Percussion in 3 Groups
timeFrame: Change from Baseline at 6 months in 3 groups
measure: Number of Teeth Sensitive to Percussion in 3 Groups
timeFrame: Change from Baseline at 12 months in 3 groups
measure: Number of Mobile Teeth in 3 Groups
timeFrame: Change from Baseline at 1 month in 3 groups
measure: Number of Mobile Teeth in 3 Groups
timeFrame: Change from Baseline at 3 month in 3 groups
measure: Number of Mobile Teeth in 3 Groups
timeFrame: Change from Baseline at 6 month in 3 groups
measure: Number of Mobile Teeth in 3 Groups
timeFrame: Change from Baseline at 12 months in 3 groups
measure: Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
timeFrame: Change from Baseline at 1 month in 3 groups
measure: Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
timeFrame: Change from Baseline at 3 months in 3 groups
measure: Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
timeFrame: Change from Baseline at 6 months in 3 groups
measure: Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
timeFrame: Change from Baseline at 12 months in 3 groups
measure: Number of Teeth With Dental Abscess in 3 Groups
timeFrame: Change from Baseline at 1 month in 3 groups
measure: Number of Teeth With Dental Abscess in 3 Groups
timeFrame: Change from Baseline at 3 months in 3 groups
measure: Number of Teeth With Dental Abscess in 3 Groups
timeFrame: Change from Baseline at 6 months in 3 groups
measure: Number of Teeth With Dental Abscess in 3 Groups
timeFrame: Change from Baseline at 12 months
measure: Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
timeFrame: Change from Baseline at 1 month in 3 groups
measure: Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
timeFrame: Change from Baseline at 3 months in 3 groups
measure: Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
timeFrame: Change from Baseline at 6 months in 3 groups
measure: Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
timeFrame: Change from Baseline at 12 months in 3 groups
measure: Number of Teeth With Root Resorption in 3 Groups
timeFrame: Change from Baseline at 1 month in 3 groups
measure: Number of Teeth With Root Resorption in 3 Groups
timeFrame: Change from Baseline at 3 months in 3 groups
measure: Number of Teeth With Root Resorption in 3 Groups
timeFrame: Change from Baseline at 6 months
measure: Number of Teeth With Root Resorption in 3 Groups
timeFrame: Change from Baseline at 12 months
measure: Number of Teeth With Any Root Lesion From Radiography in 3 Groups
timeFrame: Change from Baseline at 1 month in 3 groups
measure: Number of Teeth With Any Root Lesion From Radiography in 3 Groups
timeFrame: Change from Baseline at 3 months in 3 groups
measure: Number of Teeth With Any Root Lesion From Radiography in 3 Groups
timeFrame: Change from Baseline at 6 months in 3 groups
measure: Number of Teeth With Any Root Lesion From Radiography in 3 Groups
timeFrame: Change from Baseline at 12 months in 3 groups
Secondary outcomes:
measure: Restoration Stability
timeFrame: Change from Baseline at 1 month
measure: Restoration Stability
timeFrame: Change from Baseline at 3 months
measure: Restoration Stability
timeFrame: Change from Baseline at 6 months
measure: Restoration Stability
timeFrame: Change from Baseline at 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Faculty of Dentistry, Department of Pediatric Dentistry
Study officials:
affiliation: Marmara University
name: Ali Mentes, Prof
role: PRINCIPAL_INVESTIGATOR
References: