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

NCT07073196 | Recruiting

• 2 other identifiers: MBRUMHS - June 2025MBRU IRB-2025-110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implants

Keywords

Dental implants

Outcome Measures

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

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

Secondary Outcomes (7)

• Emergence angle of implant restorations

  Three months

• Implant success/survival rate

  After 12 months and annually for three years

• Changes in peri-implant marginal bone level

  Three and twelve months

• Implant stability measurements

  Baseline, three and twelve months

• Need for bone augmentation

  Baseline

Study Arms (2)

Narrow implants

EXPERIMENTAL

Narrow implants diameter 3.3 mm to replace missing molar tooth

Procedure: Dental implant treatment (narrow implants)

Standard implants

ACTIVE COMPARATOR

Standard implants diameter 4.5 mm to replace missing molar tooth

Procedure: Dental implant treatment (standard implants)

Interventions

Dental implant treatment (narrow implants) PROCEDURE

Replacement of a missing molar tooth with a narrow dental implant

Narrow implants

Dental implant treatment (standard implants) PROCEDURE

Replacement of a missing molar tooth with a standard dental implant

Standard implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Fully healed sites (≥ 6 months) with limited bone availability in the horizontal bucco-lingual dimension (residual bone width of ≤ 6 mm) and minimal height of 8 mm.
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.

You may not qualify if:

• 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.
• History of malignancy, radiotherapy or chemotherapy.
• Pregnant or lactating women.
• Smokers.
• Severe bruxism or parafunctional habits.
• Large occlusal discrepancies.

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Study Sites (1)

MBRU

Dubai, United Arab Emirates

RECRUITING

Central Study Contacts

Momen A Atieh, BDS, MSc, DClinDent, PhD, FPFA

CONTACT

+9714 383 8905; momen.atieh@dubaihealth.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, in which participants will be recruited and then followed up throughout a specified period of time. Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either test or control groups.

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

AE (1)