Caries,DentalNCT07323433
Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth
A study testing Chitosan Dressing in people with Caries,Dental, run by Minia University at 1 site in Egypt.
Trial summary
Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Chitosan Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2025to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with immature maxillary anterior teeth.
- Patients with caries or traumatic exposed teeth .
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome class I ASA .
- Patients who will agree to the consent and will commit to follow-up period.
Who cannot join
- Patients with mature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with signs of periapical inflammation.
- Patients who could/would not participate in a 1-year follow-up.
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Non- restorable teeth.
- cases with previously initiated endodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth:Randomized Clinical Trial
Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.
Read the detailed description
Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.
Clinically, the characteristic and the extent of pulpal hemorrhage at the exposure site are the most important outcome predictors for assessing pulpal status.
reported that excessive bleeding from the pulp revealed a significantly lower incidence of success compared with moderate bleeding. A variety of solutions and methods have been used to obtain pulpal hemostasis. Despite its limited effect on pulpal healing, sterile saline is a frequently used agent. Sodium hypochlorite (NaOCl), in concentrations of 0.5percent, achieves hemostasis without affecting pulpal repair mechanism and healing.
Hemostatic dressings have emerged as valuable adjuncts in dentistry, offering effective and efficient control of bleeding during various dental procedures. The different types of hemostatic dressings, including oxidized cellulose, gelatin- based, chitosan, and calcium-based dressings, provide localized hemostasis, reduce chair time, and improve patient outcomes.
Recently, the concept of lesion sterilization and tissue repair therapy involve the use of a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected.
Chitosan is a natural and non-toxic polysaccharide with unique biological properties such as antimicrobial, anti- fungal, anti-inflammatory, antiseptic, antitumor, hemostatic,
immune adjuvant, regenerative effect and wound healing. In dentistry, it can be used as a dental pulp capping material, mouth rinse, chewing gum, drug device for root canal disinfection, topical treatment of periodontitis and blood hemostasis after tooth extraction.
Chitosan is the most abundant biopolymer on the earth derived from chitin. It shows a remarkable effective broad spectrum antibacterial action attributed to its cationic nature. It interacts with the -ve charged bacterial cell membranes, leading to leakage of the intracellular constituents and ultimately cell death due to increasing the membrane permeability. Also, chitosan possesses a variety of other biological properties as being biodegradable, biocompatible.
- Conditions
- Caries,Dental
- Being tested
- Chitosan Dressing
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan DressingProcedure or surgery
Also called Hemcon Dressing, pulpotomy of immature permanent teeth, Cotton damped with normal saline
To evaluate the effect of chitosan dressing in pulpotomy of immature permanent teeth
| Study group | Role | What they receive |
|---|---|---|
| Group Hemcon Dressing | Active comparator | About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of Hemcon Dressing as A dressing material for hemostasis on pulp stump during pulpotomy of the immature teeth. Receives: Procedure: Chitosan Dressing |
| Group of Cotton damped with normal saline | Active comparator | About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of cotton damped with normal saline for hemostasis on pulp stump during pulpotomy of the immature teeth. Receives: Procedure: Chitosan Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Assessment of the post operative pain via Numerical Pain Rating Scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".
Measured: 72 Hours
Secondary outcomes (1)
Assessment of root completion
Assessment of root completion using standardized periapical radiograph at 6 and 12 months\periods.
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start25 Aug 2025
- Primary completion20 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Minia 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salsabil Mohammed Naguib, Minia University
- Investigators
- Lamiaa Ahmed Ebrahem, Professor, Study chair, Department of endodontics Dean of Faculty of Dentistry Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323433
- Sponsor's protocol ID
- Chitosan Dressing
- Status last verified
- Aug 2025
- First submitted
- 27 Nov 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth:Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07323433
- Acronym / sponsor ID
- Chitosan Dressing
- Conditions
- Caries,Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.
Detailed description
Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.
Clinically, the characteristic and the extent of pulpal hemorrhage at the exposure site are the most important outcome predictors for assessing pulpal status.
reported that excessive bleeding from the pulp revealed a significantly lower incidence of success compared with moderate bleeding. A variety of solutions and methods have been used to obtain pulpal hemostasis. Despite its limited effect on pulpal healing, sterile saline is a frequently used agent. Sodium hypochlorite (NaOCl), in concentrations of 0.5percent, achieves hemostasis without affecting pulpal repair mechanism and healing.
Hemostatic dressings have emerged as valuable adjuncts in dentistry, offering effective and efficient control of bleeding during various dental procedures. The different types of hemostatic dressings, including oxidized cellulose, gelatin- based, chitosan, and calcium-based dressings, provide localized hemostasis, reduce chair time, and improve patient outcomes.
Recently, the concept of lesion sterilization and tissue repair therapy involve the use of a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected.
Chitosan is a natural and non-toxic polysaccharide with unique biological properties such as antimicrobial, anti- fungal, anti-inflammatory, antiseptic, antitumor, hemostatic,
immune adjuvant, regenerative effect and wound healing. In dentistry, it can be used as a dental pulp capping material, mouth rinse, chewing gum, drug device for root canal disinfection, topical treatment of periodontitis and blood hemostasis after tooth extraction.
Chitosan is the most abundant biopolymer on the earth derived from chitin. It shows a remarkable effective broad spectrum antibacterial action attributed to its cationic nature. It interacts with the -ve charged bacterial cell membranes, leading to leakage of the intracellular constituents and ultimately cell death due to increasing the membrane permeability. Also, chitosan possesses a variety of other biological properties as being biodegradable, biocompatible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Hemcon Dressing | Active comparator | Procedure: Chitosan DressingAbout 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of Hemcon Dressing as A dressing material for hemostasis on pulp stump during pulpotomy of the immature teeth. |
| Group of Cotton damped with normal saline | Active comparator | Procedure: Chitosan DressingAbout 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of cotton damped with normal saline for hemostasis on pulp stump during pulpotomy of the immature teeth. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with immature maxillary anterior teeth.
- Patients with caries or traumatic exposed teeth .
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome class I ASA .
- Patients who will agree to the consent and will commit to follow-up period.
Key exclusion criteria (8 listed)
- Patients with mature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with signs of periapical inflammation.
- Patients who could/would not participate in a 1-year follow-up.
- Teeth with periodontal involvement.
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 |
|---|---|---|
| Chitosan DressingAlso: Hemcon Dressing, pulpotomy of immature permanent teeth, Cotton damped with normal salineTo evaluate the effect of chitosan dressing in pulpotomy of immature permanent teeth | Procedure or surgery | Group Hemcon Dressing, Group of Cotton damped with normal saline |
Primary outcome
Post Operative Pain
Time frame: 72 Hours
Assessment of the post operative pain via Numerical Pain Rating Scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".
1 secondary outcome
Assessment of root completion
Time frame: at 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Lamiaa Ahmed Ebrahem, Professor study chair
Department of endodontics Dean of Faculty of Dentistry Fayoum 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 Chitosan Dressing in people with Caries,Dental, run by Minia University at 1 site in Egypt.
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 4 inclusion and 8 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 24 Sep 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post Operative Pain (time frame: 72 Hours). 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 24 Sep 2026.