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Tooth LossNCT07468747

Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants

A study testing Subcrestal Dental Implant Placement and Crestal Dental Implant Placement in people with Tooth Loss and Edentulism, run by Gulf Medical University at 1 site in United Arab Emirates.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Dental implants are widely used to replace missing teeth and restore oral function and aesthetics. One of the key factors affecting the long-term success of dental implants is the stability of the bone surrounding the implant, particularly the crestal bone around the implant neck. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tooth Loss, Edentulism, Peri-implant Bone Loss
What is being tested?
Subcrestal Dental Implant Placement and Crestal Dental Implant Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited Arab Emirates
Study dates
30 Mar 2026to 30 Dec 2026
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years or older requiring dental implant therapy for replacement of a missing tooth in the posterior maxilla or mandible.
  • Presence of sufficient bone volume to receive a short dental implant without the need for bone augmentation procedures.
  • Patients in good general health or with controlled systemic conditions that do not contraindicate implant surgery.
  • oral hygiene, defined as a plaque score ≤25%.
  • Presence of healthy or treated periodontal tissues prior to implant placement.
  • Patients willing and able to return for follow-up visits at 3, 6, and 12 months.
  • Patients who provide written informed consent to participate in the study.

Who cannot join

  • Patients with uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders).
  • History of radiotherapy in the head and neck region.
  • Patients currently receiving bisphosphonate therapy or other medications affecting bone metabolism.
  • Active periodontal disease or untreated oral infections.
  • Heavy smokers (≥10 cigarettes per day).
  • Presence of parafunctional habits such as severe bruxism or clenching.
Show all 9Show fewer
  • Patients requiring simultaneous bone grafting or sinus augmentation at the implant site.
  • Pregnant or lactating women.
  • Patients unable or unwilling to comply with the study protocol or follow-up schedule.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site
  • Gulf Medical University

    Ajman, Ajman Emirate, 4184

Other trials in United Arab Emirates

About this study

Official title: "Influence Of Crestal Versus Subcrestal Implant Placement Levels On Peri-Implant Health And Radiographic Bone Changes Around Short Implants: A Randomized Controlled Clinical Trial."

Dental implants are widely used to replace missing teeth and restore oral function and aesthetics. One of the key factors affecting the long-term success of dental implants is the stability of the bone surrounding the implant, particularly the crestal bone around the implant neck. Implant insertion depth relative to the alveolar crest may influence peri-implant tissue health and marginal bone remodeling.

This randomized controlled clinical trial aims to evaluate the influence of implant placement depth on peri-implant health and radiographic bone changes around short dental implants placed using guided surgical protocol. All implants will be placed using the Bicon Implant System following computer-guided implant planning and surgical guide fabrication to ensure precise implant positioning.

Read more

Participants requiring implant therapy will be randomly allocated into two groups. In the test group, implants will be placed 2 mm below the crestal bone level (subcrestal placement). In the control group, implants will be placed at the crestal bone level (crestal placement). Implant placement will be performed using guided implant surgery to standardize surgical positioning and minimize variability in implant angulation and depth.

Clinical parameters related to peri-implant health, including Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index and Probing Depth during follow-up visits at 3, 6 and 12 months. In addition, standardized radiographic examinations will be performed to measure peri-implant Crestal bone level changes at 12 months.

The primary objective of this study is to determine whether subcrestal implant placement (2 mm below the bone crest) results in improved preservation of peri-implant crestal bone compared with crestal implant placement. Secondary outcomes will include assessment of peri-implant soft tissue health and overall implant stability.

The findings of this study may help clarify the optimal implant insertion depth for short implants placed using guided surgery and may contribute to improving long-term implant success and peri-implant tissue stability.

Read the detailed description

Dental implants have become a predictable and widely accepted treatment modality for replacing missing teeth and restoring oral function, aesthetics, and patient quality of life. Long-term implant success is highly dependent on the preservation of peri-implant hard and soft tissues, particularly the stability of the crestal bone surrounding the implant neck. Early marginal bone remodeling following implant placement is considered a physiological process; however, excessive bone loss may compromise implant stability, prosthetic outcomes, and long-term implant survival.

Several factors have been suggested to influence peri-implant crestal bone remodeling, including implant design, implant-abutment connection, surgical technique, loading protocol, soft tissue thickness, and implant placement depth relative to the alveolar crest. Implant insertion depth has gained increasing interest because it may influence the establishment of peri-implant biologic width, soft tissue adaptation, and the position of the implant-abutment interface relative to the crestal bone. Subcrestal implant placement has been proposed as a potential strategy to improve marginal bone stability and optimize soft tissue emergence profile; however, evidence regarding its clinical benefits compared with crestal implant placement remains inconclusive.

Peri-implant health is typically assessed through a combination of clinical and radiographic parameters. Clinical parameters such as probing depth, plaque accumulation, bleeding on probing, and soft tissue condition provide important information regarding peri-implant tissue stability and inflammation. Radiographic evaluation remains essential for detecting marginal bone changes, which are considered a key diagnostic criterion for peri-implant disease progression and long-term implant success.

  1. Periodontology 2000 - 2024 -…

The present randomized controlled clinical trial aims to evaluate the influence of implant placement depth on peri-implant health and radiographic crestal bone changes around short dental implants placed using a guided surgical protocol. The study will utilize the Bicon Implant System and a computer-guided implant placement workflow to ensure standardized implant positioning and minimize surgical variability. Digital implant planning will be performed using cone-beam computed tomography (CBCT) and virtual implant planning software. A surgical guide will be fabricated to allow accurate and reproducible implant placement according to the planned position.

Eligible participants requiring implant therapy will be randomly assigned to one of two treatment groups. In the test group, implants will be placed 2 mm below the crestal bone level (subcrestal placement). In the control group, implants will be placed at the crestal bone level (crestal placement). All implants will be placed using a guided implant surgery protocol to standardize implant angulation, position, and insertion depth.

Following implant placement, patients will undergo routine postoperative care and follow-up visits. Clinical parameters related to peri-implant health will be evaluated at 3, 6, and 12 months following implant placement. These clinical parameters will include:

Modified Plaque Index

Implant Mucosal Index

Peri-implant Mucosal Tissue Index

Probing Depth

These indices are commonly used to monitor peri-implant tissue conditions and detect early signs of inflammation or disease progression. Clinical probing and soft tissue evaluation provide essential diagnostic information regarding peri-implant mucosal health and tissue stability.

  1. Periodontology 2000 - 2024 -…

Radiographic assessment will be performed using standardized periapical radiographs to evaluate peri-implant marginal bone levels. Radiographic measurements of crestal bone level changes will be performed at baseline and at 12 months after implant placement. The distance between the implant reference point and the first bone-to-implant contact will be measured to determine peri-implant marginal bone remodeling.

The primary outcome of the study is the evaluation of radiographic peri-implant crestal bone level changes after 12 months in implants placed at crestal and subcrestal levels.

Secondary outcomes include the assessment of peri-implant soft tissue health, including plaque accumulation, mucosal inflammation, and probing depth changes over the follow-up period.

This study aims to determine whether subcrestal implant placement (2 mm below the alveolar crest) provides improved preservation of peri-implant crestal bone and peri-implant tissue health compared with crestal implant placement when using a standardized guided implant surgery protocol.

The findings of this clinical trial may contribute to improving clinical decision-making regarding optimal implant insertion depth and may provide evidence-based guidance for implant placement protocols using short implants and guided surgical techniques.

Being tested
Subcrestal Dental Implant Placement, Crestal Dental Implant Placement
Keywords
Dental Implants, Short Implants, Subcrestal Implant Placement, Peri-Implant Health, Radiographic Bone Changes
Medical subject headings
Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcrestal Dental Implant PlacementProcedure or surgery

    Placement of short dental implants using a computer-guided surgical protocol with the implant positioned 2 mm below the alveolar crest (subcrestal placement). Implant placement will be performed using a surgical guide following digital implant planning to standardize implant position, angulation, and insertion depth. Short implants from the Bicon Implant System will be used. Postoperative evaluation will include clinical assessment of peri-implant health parameters (Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth) at 3, 6, and 12 months, and radiographic assessment of peri-implant crestal bone level changes at 12 months.

  • Crestal Dental Implant PlacementProcedure or surgery

    Placement of short dental implants using a computer-guided surgical protocol with the implant positioned at the level of the alveolar crest (crestal placement). Implant placement will be performed using a surgical guide following digital implant planning to standardize implant position, angulation, and insertion depth. Short implants from the Bicon Implant System will be used. Clinical evaluation of peri-implant health parameters (Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth) will be performed at 3, 6, and 12 months, and radiographic evaluation of peri-implant crestal bone level changes will be conducted at 12 months.

Study groups in NCT07468747
Study groupRoleWhat they receive
Subcrestal Implant Placement (2 mm Subcrestal)ExperimentalParticipants in this group will receive short dental implants placed 2 mm below the crestal bone level (subcrestal placement) using a fully guided implant surgery protocol. Implant placement will be performed using the Bicon Implant System following computer-guided implant planning and surgical guide fabrication to ensure standardized implant positioning and insertion depth. Clinical parameters of peri-implant health including Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth will be evaluated at 3, 6, and 12 months. Radiographic evaluation of peri-implant crestal bone level changes will be performed at 12 months.
Receives: Procedure: Subcrestal Dental Implant Placement
Crestal Implant PlacementActive comparatorParticipants in this group will receive short dental implants placed at the crestal bone level (crestal placement) using a fully guided implant surgery protocol. Implant placement will be performed using the Bicon Implant System with computer-guided implant planning and surgical guide fabrication to standardize implant positioning and insertion depth. Clinical parameters including Modified Plaque Index, Implant Mucosal Index, Peri-implant Mucosal Tissue Index, and Probing Depth will be evaluated at 3, 6, and 12 months, and radiographic assessment of peri-implant crestal bone level changes will be performed at 12 months.
Receives: Procedure: Crestal Dental Implant Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Peri-implant Crestal Bone Level Changes

    Radiographic evaluation of peri-implant crestal bone level changes around short dental implants placed at crestal and 2-mm subcrestal levels. Cone-beam computed tomography (CBCT) scans obtained at baseline and at follow-up will be digitally superimposed using image analysis software to ensure standardized comparison. Reference lines will be established based on the implant long axis and fixed anatomical landmarks to measure vertical and horizontal bone level changes around the implant. The distance from the implant reference point to the first bone-to-implant contact will be measured on the buccal, lingual, mesial, and distal aspects. These measurements will be used to quantify peri-implant crestal bone remodeling and to compare bone level changes between the two study groups.

    Measured: 12 months after implant restoration

Secondary outcomes (4)
  1. Modified Plaque Index

    Assessment of plaque accumulation around dental implants using the Modified Plaque Index (mPI). The index will be recorded at four sites around each implant (mesial, distal, buccal, and lingual) to evaluate plaque accumulation on implant components. The scoring system will be as follows:

    Score 0: No plaque detected.

    Score 1: Plaque detected only by running a probe across the smooth marginal surface of the implant.

    Score 2: Plaque visible to the naked eye.

    Score 3: Abundance of soft plaque accumulation

    Measured: at 3, 6 and 12 months following implant restoration

  2. Implant Mucosal Index

    Evaluation of peri-implant mucosal inflammation using the Implant Mucosal Index (IMI). After drying the peri-implant area, a periodontal probe will be gently moved (≤1 mm) in an encircling motion around the implant sulcus with light pressure directed toward the soft tissue. The presence and severity of bleeding or suppuration will be recorded after a few seconds. The scoring system is as follows:

    Score 0: No bleeding.

    Score 1: Minimal, single-point bleeding.

    Score 2: Moderate, multiple-point bleeding.

    Score 3: Profuse, multiple-point bleeding.

    Score 4: Suppuration.

    Measured: 3, 6 and 12 months after implant restoration

  3. Peri-implant Mucosal Tissue Index

    Assessment of peri-implant soft tissue conditions using the Peri-implant Mucosal Tissue Index (MTI). This index evaluates the appearance, consistency, and texture of the peri-implant mucosa and is used to monitor peri-implant tissue health during follow-up. The peri-implant mucosa will be clinically examined around each implant, and the following scoring system will be used:

    Score 0: Normal mucosa.

    Score 1: Mild inflammation with slight color change and edema.

    Score 2: Moderate inflammation with redness, edema, and glazing.

    Score 3: Severe inflammation with redness, edema, and ulceration.

    Measured: 3, 6, and 12 months after implant restoration

  4. Peri-implant Probing Depth

    Measurement of probing depth around dental implants as The distance recorded in mm from the mucosal margin to the base of the pocket using a periodontal probe at six sites. This parameter will be used to evaluate peri-implant soft tissue health and detect potential peri-implant tissue changes.

    Measured: 3, 6, and 12 months after implant restoration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start30 Mar 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07468747
Sponsor's protocol ID
IRB-COD-STD-17-Sept-2025
Status last verified
Oct 2026
First submitted
9 Mar 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Subcrestal Dental Implant Placement and Crestal Dental Implant Placement in people with Tooth Loss and Edentulism, run by Gulf Medical University at 1 site in United Arab Emirates.

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 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Peri-implant Crestal Bone Level Changes (time frame: 12 months after implant restoration). 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 3 Nov 2026.

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