Necmettin Erbakan University Faculty of Dentistry
Konya, Meram, 42090, Turkey (Türkiye)
NCT Number: NCT07260357
The goal of this randomized clinical trial is to compare clinical and radiological success rates of NeoPutty MTA, ProRoot MTA and TheraCal PT pulpotomy in 4-10 years old healthy pediatric patients. The main question it aims to answer is:
Which of these 3 materials are best suited for pulpotomy treatment in the aspect of clinical and radiological success rates.
Participants will undergo a pulpotomy treatment in primary molar teeth with one of these materials used.
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Notify Me4 year–10 year
All sexes
Interventional
Not applicable
Konya, Meram, 42090, Turkey (Türkiye)
This study was conducted on primary molar patients who applied to Necmettin Erbakan University Faculty of Dentistry Department of Pedodontics for a routine check-up, did not have any systemic problems, had a score of 3 and 4 according to the Frankl Behavior Scale, and whose parents' approval could be obtained, and had a pulp-related and active caries appearance in the lower jaw. Patients between the ages of 4 and 10 who are indicated for dental pulpotomy treatment will be included.
In our prospective randomized clinical study;
Pulpotomy treatment; Infiltrative/mandibular anesthesia is applied to the primary lower molar teeth, which are in contact with the pulp and have not experienced spontaneous pain, and wait until numbness occurs. Under rubber dam isolation, soft caries in the lower primary molar tooth is removed with a steel round bur.
Removal of pulp tissue: Starting from where the pulp is exposed, 1-2 mm is removed with a water-cooled high-speed diamond round bur.
Bleeding Control: It is washed with sterile serum and the cavity is disinfected using a cotton pellet impregnated with 2.5% Sodium Hypochlorite. It is checked that there is no residual pulp tissue left. For hemostasis, a cotton pellet impregnated with physiological saline is placed in the cavity.
Control group (Pro Root MTA) Pro Root MTA consists of powder and liquid components. The liquid part is added to the powder, mixed and placed in 30 primary molars as pulpotomy material. Glass ionomer cement is placed on it as a base material and the treatment is completed by making a permanent restoration with a stainless steel crown.
Working group (NeoPUTTY MTA) NeoPUTTY MTA is in injector form and has a paste consistency. Taken using a hand tool It is placed in 30 primary molars as pulpotomy material. As a base material on it Glass ionomer cement is placed and the treatment is completed by making a permanent restoration with a stainless steel crown.
Study group (Theracal PT) Theracal PT is in the form of a resin-containing syringe and is applied directly to 30 primary molars as pulpotomy material and polymerized with the help of a radiation device. Glass ionomer cement is placed on it as a base material and the treatment is completed by making a permanent restoration with a stainless steel crown.
When the literature is examined within the scope of our research, there are a limited number of studies comparing Pro Root MTA with NeoPUTTY MTA and Theracal PT. In this thesis study, it was aimed to compare its success on the pulp with the materials in the study group by using Pro Root MTA, which has proven its success on the pulp in the literature, in the control group. After the treatment of the teeth is completed, participants will be called for 6th and 9th month checks. During the control sessions, clinical and radiological evaluations of the relevant teeth will be made and periapical radiographs will be taken, maximum one from each tooth.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Teeth were pulpotomized with Pro-Root MTA in this group.
Teeth were pulpotomized with Neo-Putty MTA in this group.
Teeth were pulpotomized with Theracal PT in this group.
Time frame: 6 months and 9 months post-treatment
Clinical success will be evaluated at 6- and 9-month follow-up examinations by assessing the following parameters: spontaneous pain, tenderness to percussion, swelling, sinus/fistula formation, and pathological mobility.
Each parameter will be recorded as positive (present) or negative (absent). Tooth mobility will be graded according to Miller's Mobility Classification (Grades 0-3).
A tooth will be considered clinically successful if all parameters are negative (no symptoms) and mobility is within Miller's Grade 0-1.
Data will be aggregated and reported as the number and percentage of teeth with clinical success for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
Time frame: 6 months and 9 months post-treatment
Radiographic success will be evaluated at 6- and 9-month follow-up visits using standardized periapical radiographs. Each radiograph will be examined for the presence or absence of the following findings: periapical radiolucency, furcal involvement, internal or external root resorption, and widening of the periodontal ligament space.
Each parameter will be recorded as positive (absent pathology) or negative (presence of any pathology).
Teeth showing no pathological findings (i.e., all parameters positive) will be classified as radiographically successful, whereas those showing any pathological change (negative) will be classified as radiographic failures.
Evaluations will be performed independently by two blinded examiners. Data will be aggregated and reported as the number and percentage of radiographically successful teeth for each pulpotomy material group (ProRoot MTA, NeoPUTTY, and TheraCal PT).
Necmettin Erbakan University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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