Oral Health Quality of Life (OHQoL) Was Assessed, the Effect of Surface Roughness on Crestal Bone Remodelling, The Effect of Surface Roughness on Peri-implant Health
Conditions
Keywords
implant surface, implant-supported overdenture, oral health quality of life, implant survival, hybrid implants, moderately rough implants
Brief summary
This study looks at how the surface texture of dental implants affects the surrounding bone and the overall gum health over time. It compares two types of implant surfaces: one partially smooth and one slightly rough. The researchers also check how these implant treatments impact patients' quality of life related to oral health after 1 year and again after 8 years.
Detailed description
This split-mouth randomized controlled trial aimed to assess the effect of surface roughness on long-term crestal bone remodelling and peri-implant health, comparing hybrid and moderately rough implants. As a secondary aim, Oral Health Quality of Life (OHQoL) was assessed after 1 and 8 function years.
Interventions
DEVICESplit-Mouth Placement of an implant with a moderately rough surface (DCC).
Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.
DEVICESplit-Mouth Placement of an implant with a hybrid surface (MSC).
Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.
Sponsors
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
In this split-mouth randomized controlled trial patients received a mandibular overdenture supported by 2 different implants. One implant had a moderately rough surface (DCC) and one implant had a hybrid surface (MSC).
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Totally edentulous for at least four months * Sufficient residual bone volume to place two implants of 4 mm in diameter and 9-11 mm in length
Exclusion criteria
* \<21 years old * Smoking * General contra-indications for oral surgery, e.g., full-dose head and neck radiation, intravenously administrated bisphosphonates and current chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of surface roughness on long-term crestal bone remodelling. | From enrollment until 8 years. | The effect of surface roughness on long-term crestal bone remodelling is evaluated by recording crestal bone loss (mm) on intra-oral periapical radiographs of the implants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Health Quality of Life (OHQoL) | Assessed after 1 and 8 function years. | The patients were asked to complete an Oral Health Impact Profile-14 (OHIP-14) questionnaire. Score varies beween min.0 and max.56. Lower values indicate better conditions. |
| Peri-implant Health: Probing pocket depth | At one year, 6 years, 8 years and 10 years of follow-up | Probing pocket depth (mm) at 4 sites around the implant |
| Peri-implant health: Bleeding on probing | At one year, 6 years, 8 years and 10 years of follow-up. | Bleeding on probing (yes/no) at 4 sites around the implant |
| Peri-implant Health: Plaque | at one year, 6 years, 8 years and 10 years of follow-up. | Plaque (yes/no) at 4 sites around the implant |
Countries
Belgium
Outcome results
None listed