Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement

NCT06760442 | Recruiting DMC

• 1 other identifier: Crestal Bone Changes
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades. Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement

Conditions

Implant Therapy; Augmentation, Alveolar Ridge

Keywords

crestal bone level changes; subcrestal implant position; crestal implant position; augmented ridge; dental implants

Outcome Measures

Primary Outcomes (1)

• Crestal bone changes

  Periapical digital radiographs to determine the amount of crestal bone lose in mm

  at baseline,3, 6 ,12 and 18 months

Secondary Outcomes (2)

• Keratinized tissue width

  at baseline, 3,6,12 and 18 months

• Patient satisfaction

  at baseline, 6 ,12 and 18 months

Study Arms (2)

Subcrestal implant placement

ACTIVE COMPARATOR

Delayed implant placement 2 mm subcrestally in missing mandibular posterior site.

Procedure: Subcrestal implant placement

Crestal implant placement

ACTIVE COMPARATOR

Delayed implant placement equicrestally in missing mandibular posterior site.

Procedure: Crestal implant placement

Interventions

Crestal implant placement PROCEDURE

Delayed implant placement equicrestally in missing mandibular posterior site.

Crestal implant placement

Subcrestal implant placement PROCEDURE

Delayed implant placement 2 mm subcrestally in missing mandibular posterior site.

Subcrestal implant placement

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients older than 21 years.
• Patients having augmented (by 50/50 particulate xenograft and autogenous bone) edentulous posterior site with vertical bone height of \> 10 mm in the mandible with a width of ridge ≥ 7 mm
• Adequate Inter-arch space for implant placement
• Favorable occlusion (no traumatic occlusion).
• Good oral hygiene.•Accepts 18 months follow-up period (cooperative patient)
• The patient provides informed consent.

You may not qualify if:

• Patients with inadequate bone volume and/ or quality
• Patients with remaining roots or with signs of acute infection related to the area of interest.
• Patients having systemic conditions that interfere with normal wound healing
• Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits .
• Smoker patients.
• Pregnant women.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International University

Cairo, Egypt

RECRUITING

Study Officials

• hani el nahas professor, Professor

  Misr International University

  STUDY CHAIR

Central Study Contacts

Hani El Nahas Professor, Professor

CONTACT

01221334637; hani.elnahass@dentistry.cu.edu.eg

Zainab Hafez Abdel Rahman, Lecturer

CONTACT

+0201221334637; Zeinab.hafez@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know whether the implant is placed crestal or subcrestal Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)