Background and objectives:
Primary and secondary implant stability remain the most relevant and reliable clinical indicator for long-term survival of dental implants. Hence modifications of surface characteristics and implant macro-designs were introduced over the last two decades to enhance osseointegration during the initial phase of healing. In this context, a variable-thread self-cutting implant design was recently introduced to improve primary stability. At present, there are limited number of studies that evaluated this variable-thread implant design. These studies were mostly experimental, of short duration and limited number of participants. Therefore, the aim of the present randomized controlled trial is to compare two implant designs (variable-thread versus standard) in terms of clinical, radiographic and patient-reported outcomes.
Methods:
A total of 24 participants, who require replacement of a posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the test group, the participants will receive variable-thread implants, while standard implants will be placed to replace missing teeth in the control group. In addition to evaluating implant stability, the trial will also report on clinical and radiographic implant outcomes at various time points.
Aged more than 18 years.
Good general health (ASA I or II, according to the American Academy of Anesthesiology).
Require replacement of a posterior single missing tooth with a dental implant.
Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline.
A healing period of less than four months postextraction at implant site.
Localized/generalized periodontitis.
Bone metabolic disease and/or taking medications that affect bone metabolism.
Long term use of non-steroidal anti-inflammatory medications.
Parallel
Dental implant treatment (variable-thread implants)
Procedure/SurgeryReplacement of a missing tooth with a dental implant with variable-thread implants
Dental implant treatment (standard implants)
Procedure/SurgeryReplacement of a missing tooth with a dental implant with standard implants
Implant stability measurements
A resonance frequency analysis device will used to measure the stability of the dental implant. The measurements will be recorded The use of a resonance frequency analysis device involves the following steps: attach the sensor to the implant, activate the device to measure resonance frequency, read the implant stability quotient (ISQ) value displayed on the device.
Changes in peri-implant marginal bone level
Changes in peri-implant marginal bone level will be assessed using standardized peri-apical radiograph
Implant survival rate
Implant survival rate will be assessed clinically after one year of implant restoration and annually up to three years. Unlike other measurements, implant survival, defined as a dental implant that remains in place and functional, will be only assessed once a year.
Biological and technical complications
Biological and technical complications will be recorded during the follow-up period
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