Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGulf Medical University
About this 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.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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%.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Subcrestal Dental Implant Placement
Procedure/SurgeryPlacement 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 Placement
Procedure/SurgeryPlacement 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Subcrestal Implant Placement (2 mm Subcrestal)Experimental treatment 1 intervention
Group B: Crestal Implant PlacementActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
12 months after implant restorationSecondary outcomes
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
Time frame
at 3, 6 and 12 months following implant restoration2
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.
Time frame
3, 6 and 12 months after implant restoration3
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.
Time frame
3, 6, and 12 months after implant restoration4
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.
Time frame
3, 6, and 12 months after implant restorationSponsors and contacts
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Source ClinicalTrials.gov
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