NCT06666595

Brief Summary

Objective: To report the implant survival rates, clinical, and radiographic outcomes of subcrestal short implant versus crestal standard length implant supported removable partial denture (RPD).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

4.3 years

First QC Date

October 26, 2024

Last Update Submit

October 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bone loss

    Evaluation of crestal bone loss around implants will be performed by periapical digital radiograph using parallel technique to avoid distortion or elongation to the image.

    3 years

Secondary Outcomes (2)

  • Plaque index (PI)

    3 years

  • Bleeding on probing (BOP)

    3 years

Study Arms (2)

Subcrestal short implant

ACTIVE COMPARATOR

Evaluation the amount of bone loss after one, two, and three years of function.

Procedure: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.

crestal standard length implant

ACTIVE COMPARATOR

Evaluation the amount of bone loss after one, two, and three years of function.

Procedure: Titanium dental implant (Conical SPI, Vitronix, Italy), Medical device that interfaces with the jawbone to support a dental prosthesis.

Interventions

Placement of titanium dental implant to retain and support Kennedy class 1 removable partial denture (RPD).The implant fuses with the bone through a process called osseointegration.

Subcrestal short implantcrestal standard length implant

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients aged 50 years or older with class 1 RPD with missing mandibular molars at least and complaining from instability of the prosthesis were recruited.
  • Medical history revealed no contraindication to implant therapy.
  • Patients have an amount of bone nearly equal to 8 mm length above the inferior alveolar canal to receive a 6 mm short implant with 2 mm subcrestal to the bone level with sufficient bone width ≥ 8mm on one side and an amount of bone equal to or more than 8 mm to receive a standard-length implant of 7.5, 9, or 10.5 mm placed at crestal bone level with sufficient bone width ≥ 8mm on the contralateral side which was examined by CBCT.

You may not qualify if:

  • Presence of active infection or inflammation in the areas intended for implant placement; \*systemic diseases such as diabetes.
  • Pregnant and lactating patients.
  • Habit of severe bruxism or clenching.
  • Treatment with therapeutic radiation to the head within the past 12 months.
  • Treatment with bisphosphonate within the past 12 months.
  • More than 10 cigarettes/day smoking habit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Mohammed A. El-Sawy, PhD

CONTACT

Mohamed T. Khater, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, Department of Prosthetic Dental Sciense, principle investigator

Study Record Dates

First Submitted

October 26, 2024

First Posted

October 30, 2024

Study Start

January 4, 2021

Primary Completion

April 20, 2025

Study Completion

August 1, 2025

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Up on reasonable request from the corresponding author

Locations