Peri-implant Bone Behaviour Using Two Drilling Techniques in Posterior Maxilla

Peri-implant Bone Behavior After Single Drilling Technique Versus Undersized Technique of Immediately Loaded Implant in Posterior Maxilla: A One-year Prospective Study

Two different drilling techniques in posterior maxilla immediate loading implant

Study Overview

• Status: Completed
• Conditions: Implant
• Intervention / Treatment: Other: Single drill system

Detailed Description

One of the surgical techniques used to enhance the primary stability of implant in low density bone was the undersized drilling technique, which has been introduced to locally optimize poor density of bone by using a final drill diameter considerably smaller compared with the implant diameter.

On the other hand, a novel hollow drill with a single drilling systems was designed. Single drilling technique shortens surgical times, removes the smallest amount of bone during implant site preparation, reduces bone damage and micro fractures, and speeds up the healing process. Additionally, because of the hollow shape, bone core may be harvested and used as an autogenous bone grafting material.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 12345
      • Mansoura University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria:

1. Patients with missing single or multiple teeth in posterior maxilla.
2. Age more than 18 years.
3. 10 mm or more vertical bone height is present.
4. Good oral hygiene.
5. Patients willing to be present during the study follow up intervals.
6. Patients free from any systemic diseases.
7. 6 mm or more ridge width is present.
8. Crown height space of at least 8 mm.
9. Patients without any para-functional habits (bruxism and clenching).

Exclusion criteria:

1. Patients with any pathological lesion or root tips at the planned surgical site.
2. Patients with inadequate bone height and thickness.
3. Smoking more than 14 cigarettes per day.14
4. Alcohol or drug abuse.
5. Patients with systemic diseases that absolutely contraindicate implant placement.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Undersized technique; New drilling tech	Other: Single drill system; New system for drilling
Active Comparator: Single drill technique; One drill system	Other: Single drill system; New system for drilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	Implant stability will be assessed at the time of implant insertion and at 3, 6 and 12 months after surgery.	12 months
Modified Sulcus Bleeding Index (mBI)	It will be measured at 3,6 and 12 months post-operatively. Clinical signs and symptoms of inflammation of peri-implant mucosa will be graded using criteria of modified sulcus bleeding index (mBI).	12 months
Peri-implant probing depth	Depth of the peri-implant sulcus will be recorded initially at the time of loading, 3, 6 and 12 months following implant loading by a graduated periodontal probe with light force to avoid undue tissue damage and over-extension into the healthy tissue	12 months
Marginal Bone Loss	For the calculation of marginal bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional and panoramic long axis in the center of the implant and bisecting it	12 months
Bone Density Recordings	Relative bone density records will be collected from the bucco-palatal view of the cross-sectional plane using the greyscale bone measuring tool	12 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: January 1, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Immediate loading; Implant stability; Single drilling technique; Posterior maxilla
• Other Study ID Numbers: A03012024OS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Two groups one single drill and undersized groups with 12 months follow up
• IPD Sharing Time Frame: 12 month
• IPD Sharing Access Criteria: All
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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