Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars

NCT04115358 | Completed Results

• 1 other identifier: MarmaraPD
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis

Keywords

Pulpotomy

Outcome Measures

Primary Outcomes (28)

• 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 Outcomes (4)

• Restoration Stability

  Change from Baseline at 1 month

• Restoration Stability

  Change from Baseline at 3 months

• Restoration Stability

  Change from Baseline at 6 months

• Restoration Stability

  Change from Baseline at 12 months

Study Arms (3)

Hyaluronic acid

EXPERIMENTAL

Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar.

Procedure: Hyaluronic acid: Gengigel teething

Formocresol

ACTIVE COMPARATOR

0,1 ml to the orifice of the root canals of the primary molar.

Procedure: Formocresol Buckley formula: Formacresol

Ferric sulfate

ACTIVE COMPARATOR

0,1 ml to the orifice of the root canals of the primary molar.

Procedure: Ferric sulfate: ViscoStat

Interventions

Hyaluronic acid: Gengigel teething PROCEDURE

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.

Hyaluronic acid

Formocresol Buckley formula: Formacresol PROCEDURE

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.

Formocresol

Ferric sulfate: ViscoStat PROCEDURE

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.

Ferric sulfate

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Systemic disease,
• Pathological mobility and resorption of the tooth,
• Pain and/or abscess,
• Non voluntary,
• The patients aren't between 5-9 years old.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Faculty of Dentistry, Department of Pediatric Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Limitations and Caveats

The limitations of this study included the unfortunate Covid-19 pandemic that interfered with the radiographic results of our study at 12th month, 8 participants did not show up to the dental appointments at 12th month and complicated the follow-up results on radiographs. However we managed to do the clinical examinations of all patients via social video conferencing devices (teledentistry).

Results Point of Contact

• Title: Prof. Dr. Ali Mentes
• Organization: Marmara University

alimentes@gmail.com

+90 2164140545

Study Officials

• Ali Mentes, Prof

  Marmara University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: October 4, 2019
• Study Start: May 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)