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NCT Number: NCT06221306

Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.

Dental implant treatment, in many cases, may be impeded by anatomical limitations, such as narrow atrophic ridges. In order to overcome that, additional surgical procedures, such as guided bone regeneration, are often required to augment the deficient hard tissue. However, additional surgical procedures often add morbidity to the patient in addition to prolonging the treatment time and raising the treatment cost.

Hence, simpler, less invasive treatment options are preferred by patients. The use of narrow diameter implants (NDI) offers the great advantage of eliminating the need for augmentation procedures.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Greater Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Hani El Nahass, Professor

CONTACT

About this study

Various methods of additional surgical procedures have been introduced to overcome reduced bone volume situations, relevant to the site, size and nature of the defect such as: maxillary sinus floor lifting and augmentation, vertical and lateral ridge augmentation by means of autogenous or bone substitutes, particulate or blocks. Lateral bone augmentation performed simultaneously with implant placement has been a well-established treatment option for horizontal ridge deficiencies.

Such additional procedures are associated with longer surgical time, greater morbidity and greater risk to complications such as: pain, infection, nerve damage, bleeding, wound dehiscence or even graft or implant failure. In addition to, higher treatment cost and a longer healing time. Furthermore, an additional surgical procedure should be considered with caution in medically compromised patients. Moreover, surgical expertise of the operator is required for performing such procedures.

NDIs showed promising results with reported survival rates 95% - 100%. However, prosthetic complications such as: abutment fracture, loss of crown retention and screw loosening were reported.

The successful outcomes of NDI have supported widening the scope to include premolars and molars, particularly where averting an additional augmentation procedure is favoured.

However, areas of concern remain evident regarding; the impact of loading on a reduced surface for osseointegration, the increased probability of fracture, the probable prosthetic complications and the loading stresses affecting crestal bone resorption. In addition to oral health-related quality of life for the patients. Limited literature is found regarding the use of NDI to restore posterior mandibular edentulous sites.

Several studies have compared NDI to SDI in pristine bone. To our knowledge few RCTs compared NDIs to SDI with simultaneous lateral bone augmentation for the treatment of atrophic posterior mandibular ridges, none assessing both crestal bone resorption in addition to oral health related quality of life (OHRQoL) assessment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients having mandibular edentulous posterior site requiring implant placement.
  • Available vertical bone height of ≥ 8 mm in the mandible and ridge width 5-6 mm in width.
  • Tooth extraction ≥3 months before surgical intervention.
  • Patients without systemic diseases interfering with implant therapy.
  • Patients aged ≥ 18 years old.
  • Good oral hygiene.

Exclusion criteria

  • Patients with systemic conditions known to affect bone metabolism and healing
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.

Treatment and study plan

Dental implant: NDI

Procedure

Placement of narrow diameter implants (NDI) (3.3) in the dentoalveolar ridge

Dental implant: SDI

Procedure

Placement of standard diameter implants (SDI) (4.1) in the dentoalveolar ridge with simaltenous bone augmentation

Primary outcomes

  1. Amount of crestal bone changes

    Time frame: 1 year

    Linear measurements (in mm) for the crestal bone level changes on periapical digital radiographs

Secondary outcomes

  1. Prosthetic complications

    Time frame: 1 year

    screw loosening, fracture of restoration

Study contacts

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

Hani El Nahass, Professor

CONTACT

[email protected]

+201000252603

Suzy Naiem, MSc

CONTACT

[email protected]

+201224785645

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Radiographic Evaluation of Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants in Conjunction With Bone Augmentation in Horizontally Deficient Posterior Mandibular Partially Edentulous Sites: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 24, 2024
Registry last updated
Jan 23, 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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