Crestal Bone Response to Narrow vs. Regular Tie-Base in Subcrestal Implants

NCT07196228 | Not Yet Recruiting

• 1 other identifier: ADMNF-00425
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This 24-month randomized clinical trial evaluates peri-implant marginal bone changes at subcrestal implants restored with narrow versus regular tie-base abutments. The study investigates whether narrow or regular tie-base abutments influence peri-implant crestal bone remodeling over 24 months. This trial assesses the effect of abutment diameter (narrow vs. regular tie-base) on marginal bone stability at subcrestal implants after 24 months. We aimed to determine if abutment diameter impacts peri-implant marginal bone levels by comparing narrow and regular tie-base abutments in a 24-month RCT.

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (1)

• Crestal bone level changes around subcrestal implants

  Radiographic assessment of peri-implant marginal bone level changes (in millimeters) comparing narrow versus regular tie-base abutments. Measurements are taken from standardized periapical radiographs at the mesial and distal aspects of each implant, using the implant shoulder as reference.

  24 months after loading

Study Arms (2)

Narrow tie-base abutment

EXPERIMENTAL

Patients received subcrestal bone-level implants restored with narrow tie-base abutments.

Device: Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment

Regular tie-base abutment

PLACEBO COMPARATOR

Patients received subcrestal bone-level implants restored with regular tie-base abutments.

Device: Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment

Interventions

Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment DEVICE

Arm 1 - Narrow tie-base abutment Intervention Name: Narrow tie-base abutment Intervention Type: Device Intervention Description: Participants received a subcrestal bone-level dental implant restored with a narrow-diameter tie-base abutment. Arm 2 - Regular tie-base abutment Intervention Name: Regular tie-base abutment Intervention Type: Device Intervention Description: Participants received a subcrestal bone-level dental implant restored with a regular-diameter tie-base abutment.

Narrow tie-base abutment; Regular tie-base abutment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old.
• Single missing tooth in a posterior quadrant, bordered by adjacent natural teeth.
• Adequate bone volume to place implants 8.5-10 mm in length and 4 mm in diameter without the need for bone or soft tissue grafting.
• Presence of a natural tooth or an implant-supported fixed restoration as an antagonist.
• Good oral hygiene with a plaque index \<25%.
• Willing and able to comply with study procedures and follow-up schedule.
• Provided written informed consent.

You may not qualify if:

• Systemic conditions or medications affecting bone metabolism (e.g., bisphosphonates, corticosteroids).
• Untreated periodontitis, persistent oral infections, or poor oral hygiene.
• Metabolic bone diseases (e.g., osteoporosis, renal insufficiency, immunodeficiency, leukocyte dysfunction).
• History of head and neck radiotherapy.
• Physical or mental disability preventing adequate oral hygiene or compliance.
• Heavy smoking (\>10 cigarettes/day).
• Alcoholism or drug abuse.
• Pregnancy or breastfeeding.
• Bruxism or oral mucosal diseases.
• Need for bone regeneration procedures before implant placement.
• Inability or unwillingness to attend follow-up visits.

Sponsors & Collaborators

• Menoufia University: lead
• Mansoura University: collaborator

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Mohammed El-Sawy, PhD

CONTACT

00201061314522; Dr_sawy@windowslive.com

Mohammed T. Khater, PhD

CONTACT

00201003854552; MohamedKhaterdentalsmile1234@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share