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Rough vs Hybrid-surface implants for maxillary All-on-4 overdentures

Rough v’s Hybrid- surface Implants for maxillary All-On-4 over-dentures: Clinical, patient and cost outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57543596
Enrollment
25
Registered
2016-08-04
Start date
2016-09-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Treatment with full-arch maxillary removable bridges Oral Health

Interventions

Pre-surgical phase Patients will be screened through clinical examination, inclusion and exclusion criteria. Recording of opposing dentition. OHRQoL by way of OHIP-14 questionnaire and collection of i

Sponsors

Southern Implants (Pty) Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Dentate and fully edentulous patients requiring treatment with full-arch maxillary over-dentures 2. Aged over 21 years

Exclusion criteria

Exclusion criteria: 1. Patients with poor oral health or motivation 2. Patients who smoke and have periodontal disease 3. Previous irradiation treatment to the head and neck 4. Bisphosphonate medication 5. Psychological disorders 6. Immunosuppressed or immunocompromised patients 7. Patients with implants placed with <25Ncm placement torque

Design outcomes

Primary

MeasureTime frame
Implant success is assessed by measuring degree of bone loss using radiographic measurements of distance from implant shoulder to marginal bone on mesial and distal aspects of implant at baseline 3 and 6 months, 1, 2, 3 and 5 years.

Secondary

MeasureTime frame
1. Patient satisfaction is measured using the Oral Health Impact Profile (OHIP 14) questionnaire before treatment, 6 months, 1, 3 and 5 years 2. Pocket depth is measured in oral examinations by the clinician at 3 and 6 months, 1, 2, 3 and 5 years 3. Bleeding on probing is measured in oral examinations by the clinician at 3 and 6 months, 1, 2, 3 and 5 years 4. Bone loss is measured by reviewing radiographic data collected at baseline then 3 and 6 months, 1, 2, 3 and 5 years 5. Cost is measured by chair time-recorded for each patient on each clinic visit and prosthetic maintenance (recorded for each patient requiring maintenance) at any time up to the end of the study (5 years)

Countries

Scotland, United Kingdom

Contacts

Public ContactDavid Offord

Outcome results

None listed

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