The success of a new dental implant in the jaw bone

Not Applicable

• Conditions: Single or multiple teeth missing in both jaws; Oral Health

• Registration Number: ISRCTN15663606
• Lead Sponsor: Straumann (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-20
• Last Update Posted: 29 August 2022
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged 18 years old and over
2. Requiring a single or partial fixed implant prosthesis (FDP) of maxillary and mandibular arch
3. Otherwise healthy patients
4. Full mouth bleeding and full mouth plaque index lower than or equal to 25%
5. Bone height for at least 4 mm-long implants
6. Bone width of at least 3 mm and 4 mm
7. Fresh extraction sockets with an intact buccal wall

Exclusion Criteria

1. Psychiatric contraindications
2. Pregnancy or nursing
3. Any interfering medication such as:
3.1. Steroid therapy
3.2. Bisphosphonate therapy
4. Alcohol or drug abuse
5. Heavy smoking (>10 cigarettes/day)
6. Radiation therapy to head or neck region within 5 years
7. Untreated periodontitis
8. Acute and chronic infections of the adjacent tissues or natural dentition
9. Severe maxillomandibular skeletal discrepancy
10. High and moderate parafunctional activity
11. Absence of opposite teeth

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Implantation survival rate (ISR) measured during a control visit every 4 months. A surviving implant is an implant that maintains its function in the mouth.<br> 2. Marginal bone loss (MBL) measured using annual periapical X-rays<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Initial implant stability quotient values (ISQ-0) and insertion torque at implant placement recorded at each scheduled visit every 4 months from implant placement<br> 2. Peri-implant soft tissue parameters recorded at each scheduled visit every 4 months from implant placement:<br> 2.1. Bleeding on probing (BoP) measured using a periodontal probe<br> 2.2. Probing depth (PD) measured using a periodontal probe<br> 2.3. Implant stability measured using ISQ values from a resonance frequencies analysis using the Osstel device<br>