Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA
ConditionDental Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust
About this trial
This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures for modSLA (SLActive, Institut Straumann AG, Switzerland) and NGA (TiUltraNP, Nobel Biocare AG, Switzerland) dental implants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: over 18 years old,
Gender: male and female.
Patient must be able and willing to follow study procedures and instructions and have capacity to provide informed consent.
Patient must require tooth extraction of a maxillary first premolar or single-rooted anterior tooth as the result of caries, endodontic failure or trauma
Disqualifiers
Systemic disease that can interfere with dental implant therapy (e.g. uncontrolled diabetes)
2 adjacent teeth requiring extraction
Greater than one wall of the socket missing - assessed at time of extraction
Any contraindications for oral surgical procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Implant Type
DevicePatients enrolled in the study will be allocated to one of three implant groups: * Group 1: NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland) * Group 2: BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland) * Group 3: TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).
Treatment groups
39 Participants
are divided into 3 treatment groupsGroup A: NGA ImplantExperimental treatment 1 intervention
Group B: BLX implant (BLX) modSLA SurfaceExperimental treatment 1 intervention
Group C: TLX implant (TLX) modSLA SurfaceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Coronal Facial Bone Maintenance
A numerical comparison of coronal facial bone thickness between the groups. CBCT scans will be compared to quantify the linear changes in crestal bone thickness at the coronal aspect of the implant (shoulder of NGA and BLX implants and rough-smooth transition of TLX implant).
Time frame
1 Year post loadingSecondary outcomes
1
Aesthetic Outcome
\- A numerical comparison of the three groups from an objective aesthetic scale derived from a panel of 2 dentists.
Time frame
1 Year post loading2
Patient Satisfaction
\- A numerical comparison of the patient satisfaction between the three groups derived from an analysis of patient questionnaires (Likert Scales).
Time frame
1 Year post loading3
Patient Satisfaction- Aesthetics
\- A numerical comparison of the aesthetic merit between the three groups derived from an analysis of patient questionnaires (Likert scales)
Time frame
1 Year post loading4
Primary Stability
A numerical comparison of primary stability measurement of the three groups (IT, RFA).
Time frame
1 Year post loadingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Barts & The London NHS Trust
Lead sponsor
Virginia Commonwealth University
Collaborator
Source ClinicalTrials.gov