Comparison of Implants With Different Implant Surfaces.

University Ghent24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

Split-Mouth Placement of an implant with a moderately rough surface (DCC).DEVICE

Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.

Split-Mouth Placement of an implant with a hybrid surface (MSC).DEVICE

Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Oral Health Sciences - Department of Periodontology and Oral Implantology - P8

Ghent, Belgium

Outcomes

Primary Outcomes

The effect of surface roughness on long-term crestal bone remodelling.

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.

Time frame: From enrollment until 8 years.

Secondary Outcomes

Oral Health Quality of Life (OHQoL)

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.

Time frame: Assessed after 1 and 8 function years.

Peri-implant Health: Probing pocket depth

Probing pocket depth (mm) at 4 sites around the implant

Time frame: At one year, 6 years, 8 years and 10 years of follow-up

Peri-implant health: Bleeding on probing

Bleeding on probing (yes/no) at 4 sites around the implant

Time frame: At one year, 6 years, 8 years and 10 years of follow-up.

Peri-implant Health: Plaque

Plaque (yes/no) at 4 sites around the implant

Time frame: at one year, 6 years, 8 years and 10 years of follow-up.

Data from ClinicalTrials.gov

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