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Dynamic navigation guided surgery accuracy to place dental implants

Accuracy of implants positioned by means of a dynamic navigation system

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN95404312
Enrollment
40
Registered
2022-03-25
Start date
2022-04-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Dental implants Oral Health

Interventions

Dental implants are positioned by means of a dynamic navigation system (XGUIDE, XNAV Technologies) and immediate post-operative CBCTs are performed in order to assess the accuracy of implant placement

Sponsors

Itesi srl
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients of both sexes aged 18 years or older 2. Requiring a single-tooth implant-supported fixed dental prosthesis (FDP) in the upper and lower jaw 3. Healthy patients 4. Full mouth bleeding and full mouth plaque index lower than or equal to 25% 5. Bone height for at least 10-mm long implants 6. Bone width of at least 5 mm and 6 mm for narrow (NP 3.75 mm) and regular (RP 4.3 mm) implants, respectively 7. Fresh extraction sockets with an intact buccal wall 8. At least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla

Exclusion criteria

Exclusion criteria: 1. General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications 2. Pregnancy or nursing 3. Any interfering medication such as steroid therapy or bisphosphonate therapy; alcohol or drug abuse 4. Heavy smoking (>10 cigarettes/day) 5. Radiation therapy to head or neck region within 5 years 6. Untreated periodontitis 7. Acute and chronic infections of the adjacent tissues or natural dentition 8. Severe maxillomandibular skeletal discrepancy 9. High and moderate parafunctional activity 10. Absence of opposite teeth

Design outcomes

Primary

MeasureTime frame
Linear and angular deviations from pre-op digital planning between implants placed via dynamic navigation surgery measured using postoperative CBCT on the day of implant placement at the end of the surgery

Secondary

MeasureTime frame
Effect of mouth opening (mm) and the right or the left side of the mouth on the accuracy of the implant positioning measured using postoperative CBCT on the day of implant placement at the end of the surgery

Countries

Italy

Outcome results

None listed

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