NCT06989684

Brief Summary

This clinical trial aims to compare two drilling protocols Underdrilling and Osseodensification for placing dental implants in patients with low bone density. The purpose is to compare which technique provides better primary and secondary implant stability in the posterior regions of the jaw with low bone density. The hypothesis is that there is no significant difference in implant stability between the two protocols.

Trial Health

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Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress48%
Sep 2025Feb 2027

First Submitted

Initial submission to the registry

May 9, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 9, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

secondary implant stability

Outcome Measures

Primary Outcomes (1)

  • Implant stability

    It compares Primary stability and Secondary stability after implant placement. Primary stability is recorded by insertion torque values from manual torque wrench. Secondary stability is recorded by resonance frequency analysis.

    12-18 months

Study Arms (2)

Osseodensification

ACTIVE COMPARATOR

Osseodensification uses special densa burs for osteotomy site compaction

Procedure: Osseodensification

Underilling

ACTIVE COMPARATOR

In Underdrilling the osteotomy is smaller than implant diameter to be placed

Procedure: Underdrilling

Interventions

Osseodensification uses specially designed burs to densify osteotomy site

Osseodensification
UnderdrillingPROCEDURE

In underdrilling the osteotomy is smaller than implant diameter to be placed

Underilling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient partially edentulous ridge after extraction of more than 6 months and with low bone density.
  • Systemically healthy patients ≥18 years of age.

You may not qualify if:

  • Smokers.
  • Pregnant or lactating females.
  • Uncontrolled systemic disease like diabetes, hypertension, hormonal therapy and hematologic diseases.
  • History of Maxillary sinus pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Study Officials

  • Dr.Ritika Arora, MDS

    PGIDS,Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinding will be performed. The patient, the outcome assessor and data analyst will be blinded to the allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 25, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations