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

NCT07468747 | Not Yet Recruiting DMC

• 1 other identifier: IRB-COD-STD-17-Sept-2025
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tooth Loss; Edentulism; Peri-implant Bone Loss

Keywords

Dental Implants; Short Implants; Subcrestal Implant Placement; Peri-Implant Health; Radiographic Bone Changes

Outcome Measures

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.

  12 months after implant restoration

Secondary Outcomes (4)

• Modified Plaque Index

  at 3, 6 and 12 months following implant restoration

• Implant Mucosal Index

  3, 6 and 12 months after implant restoration

• Peri-implant Mucosal Tissue Index

  3, 6, and 12 months after implant restoration

• Peri-implant Probing Depth

  3, 6, and 12 months after implant restoration

Study Arms (2)

Subcrestal Implant Placement (2 mm Subcrestal)

EXPERIMENTAL

Participants 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.

Procedure: Subcrestal Dental Implant Placement

Crestal Implant Placement

ACTIVE COMPARATOR

Participants 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.

Procedure: Crestal Dental Implant Placement

Interventions

Subcrestal Dental Implant Placement PROCEDURE

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.

Subcrestal Implant Placement (2 mm Subcrestal)

Crestal Dental Implant Placement PROCEDURE

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.

Crestal Implant Placement

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Mohamed Atef Sayed, Ph.D.

  Gulf Medical University

  STUDY DIRECTOR

• Marwa Mahayni, M.D.S

  Gulf Medical University

  PRINCIPAL INVESTIGATOR

• Hesham Marei, Ph.D.

  Gulf Medical University

  STUDY CHAIR

Central Study Contacts

Mohamed Atef Sayed, Ph.D

CONTACT

+971581069908; dr.mohamedatef@gmu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)