Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TDH-2024-21181 | Other Grant/Funding Number | Hacettepe University Scientific Research Projects |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is three-fold: 1. To evaluate the clinical performance of glass ionomer fissure sealants and resin fissure sealants when placed immediately after or one week following the application of silver fluoride on permanent molars affected by Molar-Incisor Hypomineralization in high caries-risk children. 2. To compare the effects of rinsing off the silver fluoride or not rinsing it off (blot-drying with cotton pellet) on sealant retention when the sealant is placed immediately after silver fluoride application, and 3. To measure the desensitizing effect of fissure sealant application following silver fluoride treatment on hypersensitive MIH molars.
Teeth will be randomized in a parallel design based on the application of restoration time (immediate or one week later), sealant material type (resin or glass ionomer), and for immediate applications, the condition of silver fluoride before restoration (dried with cotton or rinsed gently). A total of 216 permanent molars will be included in the study.
Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin based fissure sealant restoration one week after silver fluoride (AgF) application | Active Comparator | Resin-based fissure sealant restoration one week after silver fluoride (AgF) application |
|
| Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application | Active Comparator | Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application |
|
| Immediate GI-based fissure sealant after rinsing silver fluoride application | Active Comparator | Immediate GI-based fissure sealant after rinsing silver fluoride application |
|
| Immediate GI-based fissure sealant after blot-drying of silver fluoride application | Active Comparator | Immediate GI-based fissure sealant after blot-drying of silver fluoride application |
|
| Immediate resin-based fissure sealant after rinsing of silver fluoride application |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate restoration (resin- based) after blot-drying silver fluoride application | Device | Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied. | The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification. | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Caries | The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elif Ballıkaya, DDS, PhD | Contact | +905336401499 | yildirim.elif89@gmail.com | |
| Gizem Erbas Unverdi, DDS, PhD | Contact | erbasgizem@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elif Ballikaya, DDS, PhD | Hacettepe University | Principal Investigator |
| Zafer Cehreli, DDS, PhD | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41915094 | Derived | Cayiroglu N, Ballikaya E, Unverdi GE, Cehreli ZC. Effectiveness of fissure sealants following different silver fluoride application protocols in MIH-affected molars: randomized clinical study. Clin Oral Investig. 2026 Mar 31;30(4):164. doi: 10.1007/s00784-026-06856-1. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
IPD is available from the corresponding author on reasonable request
IPD is available from the corresponding author on reasonable request after October 2025
IPD is available from the corresponding author on reasonable request.
Not provided
Not provided
Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:
Group 1: Restoration one week after silver fluoride application (n=72) Subgroup 1: Resin-based fissure sealant (n=36) Subgroup 2: Glass ionomer-based fissure sealant (n=36) Group 2: Immediate restoration after silver fluoride application (n=144) Subgroup 1: Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant (n=36) Subgroup 2: Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant (n=36) Subgroup 3: Rinsing silver fluoride off and air-drying of fissures followed by resin-based fissure sealant (n=36) Subgroup 4: Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant (n=36)
Not provided
Not provided
Not provided
Not provided
Immediate resin-based fissure sealant after rinsing of silver fluoride application |
|
| GI-based fissure sealant restoration one week after silver fluoride (AgF) application | Active Comparator | GI-based fissure sealant restoration one week after silver fluoride (AgF) application |
|
|
| Immediate restoration (GI- based) after blot-drying silver fluoride application | Device | Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant |
|
| Immediate restoration (Resin based) after rinsing silver fluoride application | Device | Rinsing silver fluoride off followed by resin-based fissure sealant |
|
| Immediate restoration (GIC) after rinsing silver fluoride application | Device | Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant |
|
| Resin based fissure sealant restoration one week after silver fluoride (AgF) application | Device | Resin based fissure sealant restoration one week after silver fluoride (AgF) application |
|
| GI- based fissure sealant restoration one week after silver fluoride (AgF) application | Device | GI- based fissure sealant restoration one week after silver fluoride (AgF) application |
|
| Marginal Integrity of Sealants | The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. |
| Tooth Sensitivity | The Schiff Cold Air Sensitivity Scale (SCASS) will be used at 1, 6, 12, 18 and 24 months follow-ups to assess the presence of hypersensitivity in affected teeth by applying an air blast perpendicularly on the occlusal surface of the tooth for 1 second at a distance of 1 cm. The patient's response will be recorded according to the following scores: 0 = subject does not respond to the stimulus;
| From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. |
| Color and esthetic Changes | Discoloration of the restorations will be recorded at 1, 6, 12, 18, and 24 months follow-ups. | From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026. |
| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017001 | Tooth Demineralization |
Not provided
Not provided