NCT07850583

Brief Summary

This study aims to clinically and radiographically evaluate the efficacy of Densah burs (osseodensification) compared to the modified conventional drilling technique for early-loaded dental implants in the posterior maxilla.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

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

April 17, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Densah BursOsseodensificationDental ImplantsEarly LoadingImplant StabilityPosterior Maxilla

Outcome Measures

Primary Outcomes (1)

  • Implant Stability Quotient (ISQ)

    Implant stability measured using Resonance Frequency Analysis (RFA) with the Osstell Mentor device and SmartPeg. Measurements were recorded in four directions (every 90 degrees) and averaged per implant to provide an ISQ score (scale: 1 to 100, where higher scores indicate greater stability).

    12 months

Study Arms (2)

Densah Bur Group

EXPERIMENTAL

Osteotomy site preparation using Densah burs in reverse (counterclockwise) condensing mode at 800-1500 rpm with copious sterile irrigation and gentle pumping motion, followed by early loading after 2 months.

Procedure: Densah Bur Osseodensification

Modified Conventional Drilling Group

EXPERIMENTAL

Osteotomy site preparation using conventional drills sequentially in a clockwise direction, with the final drill operated in a counterclockwise direction, followed by early loading after 2 months.

Procedure: Modified Conventional Drilling

Interventions

Osteotomy site preparation using sequential Densah burs in reverse (counterclockwise) condensing mode at 800-1500 rpm with copious sterile saline irrigation and gentle pumping motion to preserve and compact bone.

Densah Bur Group

Sequential conventional drilling with the final drill operated in counterclockwise rotation to condense bone.

Modified Conventional Drilling Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients missing one or more posterior maxillary teeth (premolars or molars).
  • Age range between 18 and 50 years.
  • Residual vertical bone height of 10 mm or more below the maxillary sinus floor.
  • Alveolar ridge width of 6 mm or more.
  • Minimum crown height space of 8 mm.
  • Good oral hygiene.
  • Non-smokers.
  • Absence of systemic diseases that absolutely contraindicate implant surgery.
  • No parafunctional habits such as bruxism or clenching.
  • Patient compliance and willingness to attend all follow-up appointments.

You may not qualify if:

  • Pathological lesions or retained root tips at the planned surgical site.
  • Use of medications affecting bone metabolism or healing (e.g., bisphosphonates).
  • Untreated periodontal disease or poor oral hygiene.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dakhalia, 35511, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous, PartiallyBone Resorption

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth DiseasesBone Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

April 17, 2025

Primary Completion

April 17, 2026

Study Completion

July 25, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations