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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Horizontal Atrophy of Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: Dental implant: NDI; Procedure: Dental implant: SDI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzy Naiem, MSc; Phone Number: +201224785645; Email: suzy.naiem@gmail.com
• Study Contact Backup: Name: Hani El Nahass, Professor; Phone Number: +201000252603; Email: hani.elnahass@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Greater Cairo
    • Cairo, Greater Cairo, Egypt, 12613
      • Recruiting
      • Cairo University
      • Contact: Hani El Nahass, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Narrow diameter implant placement (NDI) (3.3)	Procedure: Dental implant: NDI; Placement of narrow diameter implants (NDI) (3.3) in the dentoalveolar ridge
Active Comparator: Standard diameter implant (SDI) placement (4.1) with simultaneous bone augmentation.	Procedure: Dental implant: SDI; Placement of standard diameter implants (SDI) (4.1) in the dentoalveolar ridge with simaltenous bone augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of crestal bone changes	Linear measurements (in mm) for the crestal bone level changes on periapical digital radiographs	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic complications	screw loosening, fracture of restoration	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Manal Hosny, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 13, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: blt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No