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Repairing experimental tooth root perforations with different commercial materials

Response of periodontium to MTA and Biodentine: a randomised controlled histological study on humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17574766
Enrollment
6
Registered
2017-02-02
Start date
2014-12-18
Completion date
Unknown
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root perforation Oral Health Root perforation

Interventions

Participants are randomly assigned to one of two groups, either the MTA group of the Biodentine group. Two teeth that are scheduled for extraction are randomly assigned to either being designated the

Sponsors

Clinica Odontoiatrica Salzano Tirone
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-60 years old 2. Healthy patients 3. Needing all-on-4 rehabilitation 4. Having at least two vital and periodontally healthy monoradicular teeth scheduled for extraction

Exclusion criteria

Exclusion criteria: 1. Clinically significant medical history 2. Treated with immunosuppressive therapy or immunocompromised 3. Undergoing radiotherapy in the head/neck area 4. Previously treated or under treatment with intravenous amino-bisphosphonates 5. Pregnant or breastfeeding 6. Refusing to be included in the research protocol

Design outcomes

Primary

MeasureTime frame
1. Formation of mineralised tissue over the filling material material is measured using the histological analysis at 3 months 2. PDL fibres orientation is evaluated using thehistological analysis under polarised light at 3 months 3. Presence of inflammatory cell infiltrate, classified as follows: null, when there are no inflammatory cells; mild, when there are few inflammatory cells; moderate, when inflammatory cells do not replace the normal tissue; severe, when inflammatory cells replace the normal tissue is measured using the histological analysis at 3 months

Secondary

MeasureTime frame
1. The presence or absence of a fibrous capsule formation is measured using histological analysis at 3 months 2. Root resorption is measured using histological analysis at 3 months 3. Ankylosis is measured using histological analysis at 3 months 4. Epithelial proliferation is measured using histological analysis at 3 months

Countries

Italy

Contacts

Public ContactTirone Federico
federico.tirone@gmail.com+39 017 161 9210

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026