NCT06780956

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

October 24, 2024

Last Update Submit

January 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Marginal bone loss (MBL)

    Is a non-infective remodeling process of variable entity occurring after implant placement.

    24 month

Study Arms (2)

conventional

ACTIVE COMPARATOR

Conventional Drilling Protocol

Other: Conventional

simplfied

EXPERIMENTAL

simplfied drilling protocol

Other: simplfied

Interventions

conventional drilling protocol using full sequence

conventional

3 burrs for implant placment

simplfied

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM

Murcia, 30100, Spain

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

October 24, 2024

First Posted

January 17, 2025

Study Start

December 1, 2020

Primary Completion

July 1, 2023

Study Completion

March 1, 2024

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations