MIHNCT07326241
Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia in MIH-Affected Molars
A study testing Standard Local Anesthesia, Intraoral Cryotherapy and Silver Diamine Fluoride (SDF) in people with MIH and Molar-Incisor Hypomineralization, run by Çanakkale Onsekiz Mart University at 2 sites in Turkey (Türkiye).
Trial summary
Molar-incisor hypomineralization (MIH) is a developmental enamel defect of unclear etiology that affects permanent first molars and often permanent incisors, leading to increased porosity, hypersensitivity, and poor prognosis. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- MIH, Molar-Incisor Hypomineralization, Caries Assessment
- What is being tested?
- Standard Local Anesthesia, Intraoral Cryotherapy and Silver Diamine Fluoride (SDF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 6 and 12 years.
- Systemically healthy children with no medical conditions that could interfere with dental treatment.
- Presence of at least one permanent first molar affected by molar-incisor hypomineralization (MIH), diagnosed according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- Teeth with caries lesions classified as ICDAS II codes 2, 3, 4, 5, or 6.
- Children with an adequate level of cooperation to allow completion of dental treatment under clinical conditions.
- Children and their parents/legal guardians who have read, understood, and signed the informed consent form and agreed to participate in the study.
Who cannot join
- Teeth that are not restorable.
- Children with a known allergy or hypersensitivity to any materials used in the study, including local anesthetics, silver diamine fluoride, or restorative materials.
- Presence of spontaneous pain, percussion sensitivity, or other signs/symptoms of pulpal pathology in the study tooth.
- Children with systemic diseases or conditions that could affect pain perception, healing, or cooperation during dental treatment.
- Children who are unable or unwilling to complete the clinical procedure.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Çanakkale Onsekiz Mart University, School of Dentistry
Çanakkale
Mersin University, School of Dentistry
Mersin
About this study
Official title: Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia Efficacy in Permanent Molars With Molar-Incisor Hypomineralization
Molar-incisor hypomineralization (MIH) is a developmental enamel defect of unclear etiology that affects permanent first molars and often permanent incisors, leading to increased porosity, hypersensitivity, and poor prognosis. The porous structure of MIH-affected enamel facilitates bacterial penetration, which may cause subclinical pulpal inflammation and reduce the effectiveness of local anesthesia during dental procedures. Achieving adequate anesthesia in children with MIH can be challenging, resulting in increased discomfort, anxiety, and behavioral management difficulties.
Cryotherapy has been shown to reduce pain by decreasing local inflammation and slowing nerve conduction, while silver diamine fluoride (SDF) has demonstrated efficacy in reducing dentin hypersensitivity through tubule occlusion, antibacterial activity, and remineralization. This study aims to evaluate the effects of intraoral cryotherapy and silver diamine fluoride application on pain perception and the efficacy of local anesthesia during operative dental procedures in MIH-affected permanent first molars.
Read the detailed description
The porous enamel structure of MIH-affected teeth facilitates bacterial penetration into enamel and dentin, which may lead to subclinical inflammatory reactions within the dentin-pulp complex. This inflammatory status has been associated with reduced effectiveness of local anesthesia during restorative dental procedures. In pediatric patients, difficulty in achieving adequate anesthesia may result in increased discomfort during treatment, contributing to dental anxiety, negative behavioral responses, and the need for repeated treatment sessions. Therefore, improving anesthetic efficacy in MIH-affected teeth is essential for both patient comfort and treatment quality.
Cryotherapy is a well-established method for pain management in medical practice. Its analgesic effect is attributed to reduced local inflammation, decreased nerve conduction velocity, and minimization of edema and bleeding. Previous studies have demonstrated that the use of cryotherapy following mandibular block anesthesia may reduce pain perception during dental treatment compared to conventional anesthesia alone.
Silver diamine fluoride (SDF) is a solution containing silver and fluoride ions that has been shown to effectively reduce dentin hypersensitivity by occluding dentinal tubules, promoting remineralization of demineralized tooth structure, and exerting antibacterial effects. SDF stabilizes active carious lesions and reduces sensitivity through the formation of fluorohydroxyapatite and tubule blockage. It was approved by the U.S. Food and Drug Administration in 2014 for the treatment of dentin hypersensitivity. Given its desensitizing properties, SDF may be a promising adjunctive approach to enhance anesthetic effectiveness in MIH-affected molars.
This study aims to evaluate the effects of intraoral cryotherapy and silver diamine fluoride application on pain perception and the efficacy of local anesthesia during operative dental procedures in permanent first molars affected by MIH. Pediatric patients presenting for examination and treatment at the Department of Pediatric Dentistry will be allocated into three groups: a control group, a cryotherapy group, and an SDF group. Prior to treatment, demographic and dental characteristics will be recorded, and baseline pulp sensibility responses will be assessed using electric cold testing and air stimulation (SCASS).
All treated teeth will receive local anesthesia using a standardized mandibular block technique. In the SDF group, SDF will be applied prior to anesthetic administration. In the cryotherapy group, cold application will be performed on the buccal mucosa for 5 minutes using frozen saline contained in 2-mL dental syringes wrapped in sterile gauze before treatment. Following local anesthesia, caries removal and final composite resin restorations will be completed. Pain intensity and behavioral responses during treatment will be assessed using validated pediatric pain scales. The total duration of the clinical procedure is planned to be approximately 45 minutes.
- Conditions
- MIH, Molar-Incisor Hypomineralization, Caries Assessment
- Being tested
- Standard Local Anesthesia, Intraoral Cryotherapy, Silver Diamine Fluoride (SDF)
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Local AnesthesiaOther
Local anesthesia will be administered using 1.8 mL articaine HCl with 1:100,000 epinephrine (e.g., Ultracain DS) via a standardized block anesthesia technique prior to operative treatment. (Applied in
Intraoral CryotherapyOther
Cold application to the buccal mucosa adjacent to the treated tooth for 5 minutes before local anesthetic administration.
Silver Diamine Fluoride (SDF)Other
SDF will be applied to the target tooth before local anesthetic administration according to standard clinical application procedures.
| Study group | Role | What they receive |
|---|---|---|
| Control (Standard Local Anesthesia) | Active comparator | Standard local anesthesia and operative restorative treatment only (no adjunctive SDF or cryotherapy). Receives: Other: Standard Local Anesthesia |
| Intraoral Cryotherapy + Standard Local Anesthesia | Experimental | Intraoral cryotherapy applied before anesthesia, followed by standard local anesthesia and operative restorative treatment. Receives: Other: Standard Local Anesthesia; Other: Intraoral Cryotherapy |
| Silver Diamine Fluoride (SDF) + Standard Local Anesthesia | Experimental | Silver diamine fluoride applied before anesthesia, followed by standard local anesthesia and operative restorative treatment. Receives: Other: Standard Local Anesthesia; Other: Silver Diamine Fluoride (SDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during dental treatment (FLACC)
Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
Measured: Immediately after completion of the dental procedures
Pain intensity during operative dental treatment (Wong-Baker)
The patient's current pain was assessed using the Wong-Baker Faces Pain Rating Scale, with scores ranging from 0 to 5, where higher scores indicate greater pain intensity and a worse outcome, and the assessment was performed immediately after completion of the dental procedures.
Measured: Immediately after the dental procedures were completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MIHStudies of the same condition, open and under way.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Principal investigator, Burak Carıkcıoglu, Çanakkale Onsekiz Mart University
- Investigators
- Burak Çarıkçıoğlu, Associate Professor, Principal investigator, Çanakkale Onsekiz Mart UniversitySeçkin Aksu, Assistant Professor, Study director, Mersin UniversityHilal Öztürk, Research Assistant, Study chair, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326241
- Sponsor's protocol ID
- CanakkaleOMU4
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia Efficacy in Permanent Molars With Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07326241
- Acronym / sponsor ID
- CanakkaleOMU4
- Conditions
- MIH, Molar-Incisor Hypomineralization, Caries Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 8 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.
Molar-incisor hypomineralization (MIH) is a developmental enamel defect of unclear etiology that affects permanent first molars and often permanent incisors, leading to increased porosity, hypersensitivity, and poor prognosis. The porous structure of MIH-affected enamel facilitates bacterial penetration, which may cause subclinical pulpal inflammation and reduce the effectiveness of local anesthesia during dental procedures. Achieving adequate anesthesia in children with MIH can be challenging, resulting in increased discomfort, anxiety, and behavioral management difficulties.
Cryotherapy has been shown to reduce pain by decreasing local inflammation and slowing nerve conduction, while silver diamine fluoride (SDF) has demonstrated efficacy in reducing dentin hypersensitivity through tubule occlusion, antibacterial activity, and remineralization. This study aims to evaluate the effects of intraoral cryotherapy and silver diamine fluoride application on pain perception and the efficacy of local anesthesia during operative dental procedures in MIH-affected permanent first molars.
Detailed description
The porous enamel structure of MIH-affected teeth facilitates bacterial penetration into enamel and dentin, which may lead to subclinical inflammatory reactions within the dentin-pulp complex. This inflammatory status has been associated with reduced effectiveness of local anesthesia during restorative dental procedures. In pediatric patients, difficulty in achieving adequate anesthesia may result in increased discomfort during treatment, contributing to dental anxiety, negative behavioral responses, and the need for repeated treatment sessions. Therefore, improving anesthetic efficacy in MIH-affected teeth is essential for both patient comfort and treatment quality.
Cryotherapy is a well-established method for pain management in medical practice. Its analgesic effect is attributed to reduced local inflammation, decreased nerve conduction velocity, and minimization of edema and bleeding. Previous studies have demonstrated that the use of cryotherapy following mandibular block anesthesia may reduce pain perception during dental treatment compared to conventional anesthesia alone.
Silver diamine fluoride (SDF) is a solution containing silver and fluoride ions that has been shown to effectively reduce dentin hypersensitivity by occluding dentinal tubules, promoting remineralization of demineralized tooth structure, and exerting antibacterial effects. SDF stabilizes active carious lesions and reduces sensitivity through the formation of fluorohydroxyapatite and tubule blockage. It was approved by the U.S. Food and Drug Administration in 2014 for the treatment of dentin hypersensitivity. Given its desensitizing properties, SDF may be a promising adjunctive approach to enhance anesthetic effectiveness in MIH-affected molars.
This study aims to evaluate the effects of intraoral cryotherapy and silver diamine fluoride application on pain perception and the efficacy of local anesthesia during operative dental procedures in permanent first molars affected by MIH. Pediatric patients presenting for examination and treatment at the Department of Pediatric Dentistry will be allocated into three groups: a control group, a cryotherapy group, and an SDF group. Prior to treatment, demographic and dental characteristics will be recorded, and baseline pulp sensibility responses will be assessed using electric cold testing and air stimulation (SCASS).
All treated teeth will receive local anesthesia using a standardized mandibular block technique. In the SDF group, SDF will be applied prior to anesthetic administration. In the cryotherapy group, cold application will be performed on the buccal mucosa for 5 minutes using frozen saline contained in 2-mL dental syringes wrapped in sterile gauze before treatment. Following local anesthesia, caries removal and final composite resin restorations will be completed. Pain intensity and behavioral responses during treatment will be assessed using validated pediatric pain scales. The total duration of the clinical procedure is planned to be approximately 45 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (Standard Local Anesthesia) | Active comparator | Other: Standard Local AnesthesiaStandard local anesthesia and operative restorative treatment only (no adjunctive SDF or cryotherapy). |
| Intraoral Cryotherapy + Standard Local Anesthesia | Experimental | Other: Standard Local Anesthesia, Other: Intraoral CryotherapyIntraoral cryotherapy applied before anesthesia, followed by standard local anesthesia and operative restorative treatment. |
| Silver Diamine Fluoride (SDF) + Standard Local Anesthesia | Experimental | Other: Standard Local Anesthesia, Other: Silver Diamine Fluoride (SDF)Silver diamine fluoride applied before anesthesia, followed by standard local anesthesia and operative restorative treatment. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged between 6 and 12 years.
- Systemically healthy children with no medical conditions that could interfere with dental treatment.
- Presence of at least one permanent first molar affected by molar-incisor hypomineralization (MIH), diagnosed according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- Teeth with caries lesions classified as ICDAS II codes 2, 3, 4, 5, or 6.
- Children with an adequate level of cooperation to allow completion of dental treatment under clinical conditions.
Key exclusion criteria (5 listed)
- Teeth that are not restorable.
- Children with a known allergy or hypersensitivity to any materials used in the study, including local anesthetics, silver diamine fluoride, or restorative materials.
- Presence of spontaneous pain, percussion sensitivity, or other signs/symptoms of pulpal pathology in the study tooth.
- Children with systemic diseases or conditions that could affect pain perception, healing, or cooperation during dental treatment.
- Children who are unable or unwilling to complete the clinical procedure.
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 |
|---|---|---|
| Standard Local AnesthesiaLocal anesthesia will be administered using 1.8 mL articaine HCl with 1:100,000 epinephrine (e.g., Ultracain DS) via a standardized block anesthesia technique prior to operative treatment. (Applied in | Other | Control (Standard Local Anesthesia), Intraoral Cryotherapy + Standard Local Anesthesia, Silver Diamine Fluoride (SDF) + Standard Local Anesthesia |
| Intraoral CryotherapyCold application to the buccal mucosa adjacent to the treated tooth for 5 minutes before local anesthetic administration. | Other | Intraoral Cryotherapy + Standard Local Anesthesia |
| Silver Diamine Fluoride (SDF)SDF will be applied to the target tooth before local anesthetic administration according to standard clinical application procedures. | Other | Silver Diamine Fluoride (SDF) + Standard Local Anesthesia |
Primary outcome
Pain intensity during dental treatment (FLACC)
Time frame: Immediately after completion of the dental procedures
Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
Pain intensity during operative dental treatment (Wong-Baker)
Time frame: Immediately after the dental procedures were completed
The patient's current pain was assessed using the Wong-Baker Faces Pain Rating Scale, with scores ranging from 0 to 5, where higher scores indicate greater pain intensity and a worse outcome, and the assessment was performed immediately after completion of the dental procedures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for MIH
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
Not yet recruiting
Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars
Molar-Incisor Hypomineralization (MIH)
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.
Burak Çarıkçıoğlu, Associate Professor principal investigator
Çanakkale Onsekiz Mart University
Seçkin Aksu, Assistant Professor study director
Mersin University
Hilal Öztürk, Research Assistant study chair
Çanakkale Onsekiz Mart University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Local Anesthesia, Intraoral Cryotherapy and Silver Diamine Fluoride (SDF) in people with MIH and Molar-Incisor Hypomineralization, run by Çanakkale Onsekiz Mart University at 2 sites 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 6 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: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burak Çarıkçıoğlu, Associate Professor (+905054956091, carikcioglub@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during dental treatment (FLACC) (time frame: Immediately after completion of the dental procedures). The study lists 2 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 8 Jan 2026.