PulpitisNCT04115358
Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars
A study testing Hyaluronic acid: Gengigel teething, Formocresol Buckley formula: Formacresol and Ferric sulfate: ViscoStat in people with Pulpitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- Hyaluronic acid: Gengigel teething, Formocresol Buckley formula: Formacresol and Ferric sulfate: ViscoStat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Systemic disease,
- Pathological mobility and resorption of the tooth,
- Pain and/or abscess,
- Non voluntary,
- The patients aren't between 5-9 years old.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Dentistry, Department of Pediatric Dentistry
Istanbul, 34854
About this study
Official title: Clinical and Radiographic Evaluation of Formocresol, Ferric Sulfate and Hyaluronic Acid Pulpotomies on Human Primary Teeth: A Randomized Controlled Clinical Trial
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.
Read the 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.
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.
- Conditions
- Pulpitis
- Being tested
- Hyaluronic acid: Gengigel teething, Formocresol Buckley formula: Formacresol, Ferric sulfate: ViscoStat
- Keywords
- Pulpotomy
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid: Gengigel teethingProcedure or surgery
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.
Formocresol Buckley formula: FormacresolProcedure or surgery
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.
Ferric sulfate: ViscoStatProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar. Receives: Procedure: Hyaluronic acid: Gengigel teething |
| Formocresol | Active comparator | 0,1 ml to the orifice of the root canals of the primary molar. Receives: Procedure: Formocresol Buckley formula: Formacresol |
| Ferric sulfate | Active comparator | 0,1 ml to the orifice of the root canals of the primary molar. Receives: Procedure: Ferric sulfate: ViscoStat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Teeth Sensitive to Percussion in 3 Groups
Sensitivity to biting, chewing and clinically to the percussion by a probe
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline at 12 months in 3 groups
Secondary outcomes (4)
Restoration Stability
The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Measured: Change from Baseline at 1 month
Restoration Stability
The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Measured: Change from Baseline at 3 months
Restoration Stability
The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Measured: Change from Baseline at 6 months
Restoration Stability
The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Measured: Change from Baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 May 2019
- Primary completion1 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PulpitisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Mentes, Prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115358
- Sponsor's protocol ID
- MarmaraPD
- Status last verified
- Feb 2021
- First submitted
- 9 Sep 2019
- Last updated
- 3 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Formocresol, Ferric Sulfate and Hyaluronic Acid Pulpotomies on Human Primary Teeth: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04115358
- Acronym / sponsor ID
- MarmaraPD
- Conditions
- Pulpitis
- Keywords
- Pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Posted 3 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Procedure: Hyaluronic acid: Gengigel teethingGengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar. |
| Formocresol | Active comparator | Procedure: Formocresol Buckley formula: Formacresol0,1 ml to the orifice of the root canals of the primary molar. |
| Ferric sulfate | Active comparator | Procedure: Ferric sulfate: ViscoStat0,1 ml to the orifice of the root canals of the primary molar. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Systemic disease,
- Pathological mobility and resorption of the tooth,
- Pain and/or abscess,
- Non voluntary,
- The patients aren't between 5-9 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid: Gengigel teethingApplying 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. | Procedure or surgery | Hyaluronic acid |
| Formocresol Buckley formula: FormacresolApplying 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. | Procedure or surgery | Formocresol |
| Ferric sulfate: ViscoStatApplying 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. | Procedure or surgery | Ferric sulfate |
Primary outcome
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 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 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 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 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 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 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 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 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 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 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 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 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
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
4 secondary outcomes
Restoration Stability
Time frame: Change from Baseline at 1 month
Restoration Stability
Time frame: Change from Baseline at 3 months
Restoration Stability
Time frame: Change from Baseline at 6 months
Restoration Stability
Time frame: Change from Baseline at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Mentes, Prof principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid: Gengigel teething, Formocresol Buckley formula: Formacresol and Ferric sulfate: ViscoStat in people with Pulpitis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Teeth Sensitive to Percussion in 3 Groups (time frame: Change from Baseline at 1 month in 3 groups). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.