Crestal Bone Response to Narrow vs. Regular Tie-Base in Subcrestal Implants
NCT ID: NCT07196228
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-30
2028-12-01
Brief Summary
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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.
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Detailed Description
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On the other hand, it has been observed that transmucosal abutments with convex designs can influence bone remodeling, even with platform switching, when compared to straight or concave abutments.(3,4) The hypothesis was that distancing the abutment- prosthesis interface from the implant shoulder and using narrower transmucosal abutments with platform switching could favor the maintenance of the peri- implant marginal bone level by reducing bone remodeling and the apical migration of the "biological width".
Although there is evidence regarding the influence of platform switching or abutment height on the maintenance of the peri- implant marginal bone level, the evidence on the effect of abutment diameter is limited.(5,6) Therefore, the aim of this 24- month randomized clinical trial is to evaluate changes in the peri- implant marginal bone level at implants restored narrow or regular tie-base after 24 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Narrow tie-base abutment
Patients received subcrestal bone-level implants restored with narrow tie-base abutments.
Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment
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.
Regular tie-base abutment
Patients received subcrestal bone-level implants restored with regular tie-base abutments.
Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment
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.
Interventions
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Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
20 Years
70 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Menoufia University
OTHER
Responsible Party
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Mohammed El-Sawy
Dr
Central Contacts
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Other Identifiers
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ADMNF-00425
Identifier Type: -
Identifier Source: org_study_id
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