Single Implant Crowns Supported by Narrow or Standard Diameter Implants in Molar Sites

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMohammed Bin Rashid University of Medicine and Health Sciences

About this trial

Standard dental implants require sufficient bone and spacing, which may not be available in all patients. To address these limitations, narrow diameter implants (≤3.5 mm) have been introduced as a less invasive alternative, especially useful for medically compromised patients or those avoiding bone grafts. However, narrow implants made of pure titanium have shown long-term biological and technical concerns.

The introduction of titanium-zirconium (TiZr) alloy has improved mechanical strength, and several studies have demonstrated favorable outcomes with narrow TiZr implants. Yet, evidence remains limited regarding their exclusive use in high-load posterior (molar) regions. Prior studies report conflicting failure rates, potentially linked to prosthetic design and occlusal forces, but lack quantitative analysis of bite forces or prosthetic angles.

Emergence angle, prosthetic platform width, and implant-abutment connection may all influence implant stability and peri-implant tissue health. A newly introduced TorcFit™ connection may offer better stress distribution and torque resistance, but its clinical relevance-especially in narrow implants used for molars-remains untested.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged ≥ 18 years.

Require replacement of single missing molar tooth with dental implant in fully healed sites.

Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).

Intact adjacent teeth and opposing dentition.

Disqualifiers

Localized/generalized periodontitis.

Any medical condition that may contraindicate implant treatment (Bornstein et al., 2009).

Bone metabolic disease and/or taking medications that affect bone metabolism.

Long term use of non-steroidal anti-inflammatory medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dental implant treatment (narrow implants)

    Procedure/Surgery

    Replacement of a missing molar tooth with a narrow dental implant

  • Dental implant treatment (standard implants)

    Procedure/Surgery

    Replacement of a missing molar tooth with a standard dental implant

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Narrow implantsExperimental treatment 1 intervention
Group B: Standard implantsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peri-implant mucosal recession rate

The peri-implant mucosal margin will be assessed by measuring the clinical crown height and recorded as yes/no

Time frame
Peri-implant mucosal recession rate will be assessed at three and twelve months

Secondary outcomes

1

Emergence angle of implant restorations

Emergence angle of implant restorations will be measured on radiographs by recording the angle between the implant long axis and a line tangent to implant restorations

Time frame
Three months
2

Implant success/survival rate

Implant success/survival rate will be assessed clinically after one year of implant restoration and annually up to three years. A successful implant is the one that will meet the criteria proposed by the European Federation of Periodontology (Albrektsson and Isidor, 1994), while a survived implant is the one that will remain in function but without meeting the success criteria. An implant is considered failed when it will be removed.

Time frame
After 12 months and annually for three years
3

Changes in peri-implant marginal bone level

Changes in peri-implant marginal bone level will be assessed standardized periapical radiographs.

Time frame
Three and twelve months
4

Implant stability measurements

Implant stability measurements will be recorded using an electronic handheld device (Osstell Beacon, W\&H, Göteborg, Sweden). The device uses the resonance frequency analysis (RFA) to measure the implant stiffness in implant stability quotient (ISQ) units (Sennerby and Meredith, 1998, Sennerby and Meredith, 2008). The ISQ scale ranges from 0 to 100 with values higher than 65 ISQ indicating a satisfactory implant stability (Atieh et al., 2012, Atieh et al., 2014, Sennerby and Meredith, 2008).

Time frame
Baseline, three and twelve months

Other outcomes

Sponsors and contacts

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