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New treatment option for Root Canal Infection
Official title Clinical Trial of Modified Endocrown and Personalized Post-core and Crown for Large-area Tooth Defects After Root Canal Treatment
ClinicalTrials.gov ID: NCT07206108
What this study is testing
- What it's testing
- This study intends to adopt a multicenter, randomized controlled, single-blind, non-inferiority clinical trial design. 246 premolars that meet the inclusion criteria after complete root canal treatment will be selected from the clinical practice and randomly divided into two groups.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 1: The affected tooth was a premolar that had undergone complete root canal treatment for two weeks. Both imaging and clinical examinations indicated...
- 2: The oral hygiene condition is good. There is no periodontitis or combined periodontal and endodontic lesions with a probing depth greater than...
- 3: At least 50% of the crown structure should be retained, or at least two crown walls should be retained, and the tooth defect should not be located...
- 4: The affected tooth has sufficient root length to ensure a pedicle-crown ratio of at least 1:1 and a root tip closure of at least 3 mm.
- 5: The occlusal function is normal.
You likely can't join if
- 1: Root canal retreatment of the affected tooth.
- 2: Loosening \> I °, alveolar bone resorption exceeds 1/3 of the root length.
- 3: Loss of adjacent teeth and occlusal teeth.
- 4: The patient is in the preconception period and the pregnancy period.
- 5: Patients with night bruxism, deep overbite, tight occlusion or severe limited mouth opening, and temporomandibular joint diseases.
- 6: Patients who have a history of chemotherapy or radiotherapy in the head and neck region within 5 years, suffer from severe systemic and organic...
See the full eligibility criteria
- 1: The affected tooth was a premolar that had undergone complete root canal treatment for two weeks. Both imaging and clinical examinations indicated no abnormal periapical reactions.
- 2: The oral hygiene condition is good. There is no periodontitis or combined periodontal and endodontic lesions with a probing depth greater than 4mm. There are no severe oral bad habits (such as smoking more than 20...
- 3: At least 50% of the crown structure should be retained, or at least two crown walls should be retained, and the tooth defect should not be located under the gums or can be aligned with the gums or located above the...
- 4: The affected tooth has sufficient root length to ensure a pedicle-crown ratio of at least 1:1 and a root tip closure of at least 3 mm.
- 5: The occlusal function is normal.
- 6: Treated premolars will not be used as abutments for FPD or RPD restoration.
- 1: Root canal retreatment of the affected tooth.
- 2: Loosening \> I °, alveolar bone resorption exceeds 1/3 of the root length.
- 3: Loss of adjacent teeth and occlusal teeth.
- 4: The patient is in the preconception period and the pregnancy period.
- 5: Patients with night bruxism, deep overbite, tight occlusion or severe limited mouth opening, and temporomandibular joint diseases.
- 6: Patients who have a history of chemotherapy or radiotherapy in the head and neck region within 5 years, suffer from severe systemic and organic diseases, have physical disabilities or mental illnesses that affect...
- 7: The affected tooth has imaging manifestations of absorption inside and outside the root, or the anatomical morphology of the root and root canal is poor, such as short and small roots, curved root canals, small roots...
- 8: The researchers consider other situations that are not suitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.