Simplified vs Conventional Drilling Protocol for Implant Placment
Peri-implant Tissue Stability of Simplified vs Conventional Drilling Protocol Randomized Trial With 24-month Follow-up.
1 other identifier
interventional
46
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2020
Typical duration for phase_3
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 24, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedJanuary 17, 2025
January 1, 2025
2.6 years
October 24, 2024
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 COMPARATORConventional Drilling Protocol
simplfied
EXPERIMENTALsimplfied drilling protocol
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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