A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies
Primary Purpose
Pulpitis
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies
eugenol based zinc oxide and Ferric Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis
Eligibility Criteria
Inclusion Criteria:
- Children aged 3 to 7 years old.
- Carious teeth with clinical and radiographic diagnosis of reversible pulpitis
- Only teeth having no more than one third of their roots undergoing physiologic resorption were included.
- Restorable with stainless steel crown
Exclusion Criteria:
- clinical or radiographic evidence of pulp degeneration
- excessive bleeding
- pathologic mobility
- swelling or fistula
- history of spontaneous and nocturnal pain
- tenderness to percussion or palpation
- external or internal root resorption : {The primary teeth undergo resorption due to developing permanent teeth which is considered normal. Presence of internal root resorption will be considered as a failure (pathological change). Alternatively external root resorption will not be considered as a failure (physiological change}
- inter radicular or periapical radiolucency.
Sites / Locations
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
non-eugenol based ZOE and Ferric Sulfate
eugenol based zinc oxide and Ferric Sulfate
Arm Description
non-eugenol based ZOE and Ferric Sulfate in primary molar pulpotomy procedures.
eugenol based zinc oxide and Ferric Sulfate in primary molars pulpotomies procedures.
Outcomes
Primary Outcome Measures
Clinical success rate
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility.
Radiographic success rate
Normal periodontal ligament space
No inter-radicular or periapical radiolucency
No internal or external root resorption
Secondary Outcome Measures
Full Information
NCT ID
NCT05557812
First Posted
September 7, 2022
Last Updated
February 6, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT05557812
Brief Title
A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies
Official Title
A Comparative Assessment Clinical Trial Comparing Ferric Sulfate With Zinc-oxide Eugenol and Non-eugenol Based Materials for Pulpotomy in Primary Molar Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Internal resorption in the most common cause of failure in FS pulpotomies in primary molars. This has been attributed to the release of free eugenol from the zinc and eugenol mixture of the base material over the pulp tissue. Zinc oxide-eugenol (ZOE) paste is the most common base material placed over the infected pulp tissues during pulpotomies of primary molars, however the evidence suggests that the eugenol component has been associated with the failure of the vital pulp treatment in primary molars. Cavit (3M, US) is another base material that contains Zinc-oxide, zinc sulphate, and calcium salts without eugenol. The effectiveness of non-eugenol based Zinc oxide as a base material over ferric sulphate treated pulp has not been explored. The hypothesis is that the non-eugenol based ZOE could be used as an alternate to eugenol based ZOE and thereby avoid the radiological failures. Therefore, this randomized controlled clinical split-mouth trial aimed to evaluate and compare the effect of eugenol and non-eugenol based ZOE on the success of primary tooth pulpotomies where FS is used as a medicament.
Detailed Description
Pulpotomy vital pulp therapy is a frequently performed therapeutic procedures in pediatric dentistry. This procedure aims to preserve the vitality of primary teeth or immature permanent teeth with pulp exposure due to caries and with no evidence of radiographical pathology. Pulpotomies eliminate the bacterial infection from the tooth by the partial removal of the apical pulp tissue, followed by the placement of a pulp medicament and a base material on top of it. The most frequently used medicaments in pulpotomy vital therapy are formocresol (FC), mineral trioxide aggregate (MTA), ferric sulphate (FS), calcium hydroxide (CH), Bio-dentine (BD) and laser. Due to its high success rate, FC is a commonly used medicament, and it is described as the 'gold standard' for pulpotomy procedures. However, FC is a controversial medicament, because ethe major component of formocresol; formaldehyde, has been classified by the International Agency for Research on Cancer (IARC) as a possible human carcinogen. Consequently, several studies were conducted to assess the toxic effects of using FC, and the evidence suggested that, in the dental setting, there is very low exposure of formaldehyde, and it should not exhibit any carcinogenic actions. Despite these findings dentists in Europe still have some concerns regarding FC usage in vital pulp therapy, and alternatively prefer other medicaments over FC, Such as Ferric Sulfate (FS); which is their medicament of choice. FS is a hemostatic agent that is commonly used for pulpotomies in primary teeth, this agent helps in retaining the vitality of the tooth by forming a protective metal protein clot over the vital pulp tissue. Therefore, FS has been widely studied over the world, and the evidence suggested that both FC and FS showed comparable success rates clinically and radiographically as medicaments for pulpotomies in primary molars. However, FC was anticipated to achieve a 10% higher success over FS in a Trial Sequential Analysis (TSA) that was conducted at 24 months' time interval comparing the radiographic success of FC and FS. These finding can be explained by the fact that internal resorption in the most common cause of failure in FS pulpotomies in primary molars. This has been attributed to the release of free eugenol from the zinc and eugenol mixture of the base material over the pulp tissue. Zinc oxide-eugenol (ZOE) paste is the most common base material placed over the infected pulp tissues during pulpotomies of primary molars, however the evidence suggests that the eugenol component has been associated with the failure of the vital pulp treatment in primary molars. Cavit (3M, US) is another base material that contains Zinc-oxide, zinc sulphate, and calcium salts without eugenol. This has been used a temporary restorative material with excellent sealing capability. It has been shown that this material induces an alkaline potential hydrogen (pH), which in terms plays an important role in hard tissue formation, by the neutralization of the lactic acid formation from osteoclasts and the activation of the alkaline phosphatases. The effectiveness of non-eugenol based Zinc oxide as a base material over ferric sulphate treated pulp has not been explored. The hypothesis is that the non-eugenol based ZOE could be used as an alternate to eugenol based ZOE and thereby avoid the radiological failures. Therefore, this randomized controlled clinical split-mouth trial aimed to evaluate and compare the effect of eugenol and non-eugenol based ZOE on the success of primary tooth pulpotomies where FS is used as a medicament.
Null hypothesis: In primary molar pulpotomy, non-eugenol based ZOE placed over ferric sulphate do not show higher success rate compared to eugenol based zinc oxide as a base material
Alternate hypothesis: In primary molar pulpotomy, non-eugenol based ZOE placed over ferric sulphate show a higher success rate compared to eugenol based zinc oxide as a base material
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
non-eugenol based ZOE and Ferric Sulfate
Arm Type
Experimental
Arm Description
non-eugenol based ZOE and Ferric Sulfate in primary molar pulpotomy procedures.
Arm Title
eugenol based zinc oxide and Ferric Sulfate
Arm Type
Experimental
Arm Description
eugenol based zinc oxide and Ferric Sulfate in primary molars pulpotomies procedures.
Intervention Type
Drug
Intervention Name(s)
non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies
Other Intervention Name(s)
CAVIT
Intervention Description
non-eugenol based ZOE base material placed over ferric sulphate, during vital pulp therapy (pulpotomy) in primary molars
Intervention Type
Drug
Intervention Name(s)
eugenol based zinc oxide and Ferric Sulfate
Other Intervention Name(s)
Intermediate Restorative Material (IRM)
Intervention Description
eugenol based zinc oxide base material placed over Ferric Sulfate medicament, during vital pulp therapy (pulpotomy) in primary molars
Primary Outcome Measure Information:
Title
Clinical success rate
Description
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility.
Time Frame
36 months
Title
Radiographic success rate
Description
Normal periodontal ligament space
No inter-radicular or periapical radiolucency
No internal or external root resorption
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged 3 to 7 years old.
Carious teeth with clinical and radiographic diagnosis of reversible pulpitis
Only teeth having no more than one third of their roots undergoing physiologic resorption were included.
Restorable with stainless steel crown
Exclusion Criteria:
clinical or radiographic evidence of pulp degeneration
excessive bleeding
pathologic mobility
swelling or fistula
history of spontaneous and nocturnal pain
tenderness to percussion or palpation
external or internal root resorption : {The primary teeth undergo resorption due to developing permanent teeth which is considered normal. Presence of internal root resorption will be considered as a failure (pathological change). Alternatively external root resorption will not be considered as a failure (physiological change}
inter radicular or periapical radiolucency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayakumar Jayaraman, BDS MDS PhD
Phone
(804) 828-2362
Email
jayaramanj@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayakumar Jayaraman, BDS MDS PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies
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