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

NCT06770231 | Completed

• 1 other identifier: A03012024OS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Two different drilling techniques in posterior maxilla immediate loading implant

Conditions

Implant

Keywords

Implant stability; Immediate loading; Single drilling technique; Posterior maxilla

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Undersized technique

EXPERIMENTAL

New drilling tech

Other: Single drill system

Single drill technique

ACTIVE COMPARATOR

One drill system

Other: Single drill system

Interventions

Single drill system OTHER

New system for drilling

Single drill technique; Undersized technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 12345, Egypt

Location

Related Publications (1)

• Sadek MAG, Amer MZ, El-Gohary N, Elsheikh HA. Peri-implant bone behavior after single drilling technique versus undersized drilling technique of immediately loaded implant in posterior maxilla: a one-year prospective study. BMC Oral Health. 2025 Jun 21;25(1):956. doi: 10.1186/s12903-025-06360-0.

  PMID: 40544298 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical demonstrator oral and maxillofacial surgery Mansoura university

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 13, 2025
• Study Start: May 30, 2023
• Primary Completion: May 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 month
• Access Criteria: All

Locations

EG (1)