Variable-thread Versus Standard Dental Implants for Replacing Missing Teeth

NCT ID: NCT06808854

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-11-01

Brief Summary

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.

Detailed Description

Introduction

Implant stability is a prerequisite for successful osseointegration and implant survival as implant micro-motion can compromise osseointegration and lead to implant failure. Maintenance of implant stability over time has been considered one of the implant success criteria that is identified at the primary or secondary level. Primary implant stability occurs as a result of bone compression and mechanical interlocking between implant surface and bone at the time of implant placement. Therefore, primary stability can be largely influenced by implant surface characteristics and implant design in terms of microstructure, thread design and geometry as well as bone quality and quantity. In contrast, secondary implant stability is a biologically mediated process by which bone matures and remodels at the bone-implant interface.

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, an implant design was recently introduced to improve primary stability particularly in areas of poor bone quality such as the posterior maxilla. The recently introduced implant has self-cutting self-drilling body with variable thread configurations that are designed to allow controlled compaction and condensation of bone during insertion thus enhancing the initial bone to implant contact. It is claimed that high primary stability is achieved by a controlled bone compaction and densification mechanism resulting from the double variable thread design and the apical sharp threads. In addition, the implant is made up of titanium-zirconium alloy that provide strength, high resistance to loading and biocompatibility. Its moderately rough hydrophilic sandblasted and acid-etched (SLActive) surface can also improve bone-implant contact during the early phase of osseointegration.

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.

Objectives:

The aims of the present randomized controlled trial are:

• To evaluate implant stability.
• To evaluate the changes in peri-implant marginal bone level.
• To evaluate implant survival rates.
• To evaluate biological and technical complications during the follow-up period.

Conditions

Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Variable-thread implants

The placement of a variable-thread implant to replace single missing posterior tooth

Group Type: EXPERIMENTAL

Dental implant treatment (variable-thread implants)

Intervention Type: PROCEDURE

Replacement of a missing tooth with a dental implant with variable-thread implants

Standard implants

The placement of standard implant to replace single missing posterior tooth

Group Type: ACTIVE_COMPARATOR

Dental implant treatment (standard implants)

Intervention Type: PROCEDURE

Replacement of a missing tooth with a dental implant with standard implants

Interventions

Dental implant treatment (variable-thread implants)

Replacement of a missing tooth with a dental implant with variable-thread implants

Intervention Type: PROCEDURE

Dental implant treatment (standard implants)

Replacement of a missing tooth with a dental implant with standard implants

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.
• Good compliance and commitment to attend follow-up review appointments.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mohammed Bin Rashid University of Medicine and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Momen Atieh

Professor and Chair (Periodontology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MBRU

Dubai, , United Arab Emirates

Site Status: RECRUITING

Countries

United Arab Emirates

Central Contacts

Momen Atieh, BDS, MSc, DClinDent, PhD

Role: CONTACT

momen.atieh@mbru.ac.ae

+9714 383 8905

Facility Contacts

Momen Atieh, BDS, MSc, DClinDent, PhD

Role: primary

momen.atieh@mbru.ac.ae

+971 4 383 8905

Other Identifiers

MBRUMHS - 2024

Identifier Type: -

Identifier Source: org_study_id