Variable-thread Versus Standard Dental Implants for Replacing Missing Teeth

NCT06808854 | Recruiting

• 1 other identifier: MBRUMHS - 2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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.

  "during implant placement procedure" "1 year" "up to 24 weeks" "through study completion, an average of 1 year".

Secondary Outcomes (3)

• Changes in peri-implant marginal bone level

  "during implant placement procedure" "1 year" "up to 24 weeks" "through study completion, an average of 1 year".

• Implant survival rate

  "1 year" "up to 24 weeks" "through study completion, an average of 1 year".

• Biological and technical complications

  "1 year" "up to 24 weeks" "through study completion, an average of 1 year".

Study Arms (2)

Variable-thread implants

EXPERIMENTAL

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

Procedure: Dental implant treatment (variable-thread implants)

Standard implants

ACTIVE COMPARATOR

The placement of standard implant to replace single missing posterior tooth

Procedure: Dental implant treatment (standard implants)

Interventions

Dental implant treatment (variable-thread implants) PROCEDURE

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

Variable-thread implants

Dental implant treatment (standard implants) PROCEDURE

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

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 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.

You may not qualify if:

• 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.

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 Atieh, BDS, MSc, DClinDent, PhD

CONTACT

+9714 383 8905; momen.atieh@mbru.ac.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 and Chair (Periodontology)

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: January 7, 2025
• First Posted: February 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-02

Locations

AE (1)