Bone LossNCT07196228
Crestal Bone Response to Narrow vs. Regular Tie-Base in Subcrestal Implants
A study testing Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment in people with Bone Loss, run by Menoufia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Crestal Bone Changes at Subcrestal Bone-level Implants With Narrow or Regular Tie-base: A Randomized Controlled Trial
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.
Read the detailed description
INTRODUCTION The preservation of supracrestal peri- implant soft tissues plays a crucial role in maintaining bone tissue stability.(1) In recent decades, it has been suggested that peri- implant marginal bone loss is influenced by several factors, including the surface characteristics of the implant neck, the implant- abutment, abutment height, platform switching, and abutment dis/reconnection.(2) Limiting these disconnections has been shown to improve the maintenance of the peri- implant marginal bone level.
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
- Bone Loss
- Being tested
- Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Narrow tie-base abutment | Experimental | Patients received subcrestal bone-level implants restored with narrow tie-base abutments. Receives: 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. Receives: Device: Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196228
- Sponsor's protocol ID
- ADMNF-00425
- Status last verified
- Jan 2025
- First submitted
- 19 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Crestal Bone Changes at Subcrestal Bone-level Implants With Narrow or Regular Tie-base: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07196228
- Acronym / sponsor ID
- ADMNF-00425
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION The preservation of supracrestal peri- implant soft tissues plays a crucial role in maintaining bone tissue stability.(1) In recent decades, it has been suggested that peri- implant marginal bone loss is influenced by several factors, including the surface characteristics of the implant neck, the implant- abutment, abutment height, platform switching, and abutment dis/reconnection.(2) Limiting these disconnections has been shown to improve the maintenance of the peri- implant marginal bone level.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow tie-base abutment | Experimental | Device: Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutmentPatients received subcrestal bone-level implants restored with narrow tie-base abutments. |
| Regular tie-base abutment | Placebo comparator | Device: Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutmentPatients received subcrestal bone-level implants restored with regular tie-base abutments. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutmentArm 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. | Device | Narrow tie-base abutment, Regular tie-base abutment |
Primary outcome
Crestal bone level changes around subcrestal implants
Time frame: 24 months after loading
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No. Up on reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Name (Arm 1): Narrow tie-base abutment Intervention Name (Arm 2): Regular tie-base abutment in people with Bone Loss, run by Menoufia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed El-Sawy, PhD (00201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone level changes around subcrestal implants (time frame: 24 months after loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.