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NCT Number: NCT06760442

Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement

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

Recruiting

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Materials and methods: This prospective, parallel, randomized controlled clinical trial will have 36 participants who need implant placement at the posterior mandibular area where they previously received horizontal bone augmentation. They will be randomly allocated into 2 groups, where group A (test) will receive dental implant placed subcrestally and group B (control) will receive implant placed equicrestally. Crestal bone loss will be assessed by periapical radiographs at implant placement (T0), 3 months (T3), 6 months (T6), 12 months (T12) and 18 months (T18) following implant placement. Keratinized tissue width, and soft tissue thickness will be measured clinically by periodontal probe at the same time points. Buccal bone changes will be evaluated at 18 months compared with the preoperative cone beam computed tomography by fusion module. Patient satisfaction will be recorded at the end of the trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Subcrestal implant placement

Procedure

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

Crestal implant placement

Procedure

Delayed implant placement equicrestally in missing mandibular posterior site.

Primary outcomes

  1. Crestal bone changes

    Time frame: at baseline,3, 6 ,12 and 18 months

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

Secondary outcomes

  1. Keratinized tissue width

    Time frame: at baseline, 3,6,12 and 18 months

    Keratinized tissue width using periodontal probe in mm

  2. Patient satisfaction

    Time frame: at baseline, 6 ,12 and 18 months

    Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Hani El Nahas Professor, Professor

CONTACT

[email protected]

01221334637

Zainab Hafez Abdel Rahman, Lecturer

CONTACT

[email protected]

+0201221334637

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

Radiographic Evaluation of Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement in Mandibular Posterior Augmented Ridge. A Randomized Controlled Clinical Trial.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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