Simplified vs Conventional Drilling Protocol for Implant Placment

January 16, 2025 updated by: Artiom Lijnev, Universidad Católica San Antonio de Murcia

Peri-implant Tissue Stability of Simplified vs Conventional Drilling Protocol Randomized Trial With 24-month Follow-up.

Despite the growing interest in these alternative drilling protocols, there is a lack of robust clinical evidence evaluating their long-term effects on MBL. The aim of the present study was therefore, to evaluate the effect of implant site preparation technique (conventional drilling versus simplfied) on change in the marginal bone level and insertion torque.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30100
        • UCAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients without any systemic pathologies that could be considered grounds for absolute contraindication.
  • Adult patients who agreed to participate in the study and signed the informed consent form.
  • Patients who smoked fewer than ten cigarettes per day.
  • Patients who were not completely edentulous.
  • Patients who were partially edentulous in the posterior maxillary or mandibular area and did not require the use of regenerative techniques.
  • Patients with an area of healed, mature bone at least three months post-extraction.

Exclusion Criteria:

  • Patients missing teeth in the esthetic zones 13-23 and 33-43 (second and fifth sextants).
  • Patients who smoked more than ten cigarettes per day.
  • Patients with a bleeding index greater than 30%.
  • Patients with dental caries or periodontal disease.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional
Conventional Drilling Protocol
Other: Conventional
conventional drilling protocol using full sequence
Experimental: simplfied
simplfied drilling protocol
Other: simplfied
3 burrs for implant placment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone loss (MBL)
Time Frame: 24 month
Is a non-infective remodeling process of variable entity occurring after implant placement.
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

January 16, 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 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CE092002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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