Comparative Evaluation of the Clinical Efficacy of Short Implants With Standard-Length Implants - a Randomised Controlled Trial

NCT06520332 | Not Yet Recruiting

• 1 other identifier: 02_D012_00040
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal disease , especially in its advanced stages , is one of the main cause for tooth loss .Tooth replacement options include dental implants , fixed partial denture , removable partial denture and complete dentures . Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. Although conventional implants cannot be placed in every site due to resorption of the alveolar socket after extraction. Thus short implants can be used as an alternative . Hence, this study aims at comparing the clinical efficacy of short implants with standard length implants placed in native or augmented bone in patients with a history of periodontitis.

Conditions

Dental Implant

Keywords

Dental implant

Outcome Measures

Primary Outcomes (1)

• The primary outcome that will be assessed is implant survival rate.

  The primary objective of this randomised controlled clinical trial will be to compare the survival rate of short implants (≤ 6 mm ) and standard-length implants (≥ 10 mm) in patients with a history of periodontitis; through clinical and radiographic analysis.

  6 months

Study Arms (2)

10 Short implants will be placed in the residual vertical bone height of 5 to 8mm .

EXPERIMENTAL

One short dental implant will be placed whose length will be less than or equal to 6mm.

Procedure: Dental Implant Surgery - short implant group (less than or equal to 6mm)

10 Standard implants of length ≥ 10mm will be placed in augmented/native bone .

ACTIVE COMPARATOR

This Conventional Dental implant group will act as control.

Procedure: Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm)

Interventions

Dental Implant Surgery - short implant group (less than or equal to 6mm) PROCEDURE

A mucoperiosteal flap will be raised in edentulous ridge. A short dental implant (experimental group) will be placed according to the standard protocol. The platform of the implant will be placed 2 to 3 mm below CEJ of adjacent teeth. The surgical wound closure will be coapted with mattress and single interrupted sutures

10 Short implants will be placed in the residual vertical bone height of 5 to 8mm .

Dental Implant Surgery - Conventional implant group (greater than or equal to 10mm) PROCEDURE

A mucoperiosteal flap will be raised in edentulous ridge. A standard length implant ( comparative group) ( ≥10mm) will be placed according to the standard protocol in the augmented/native bone . The platform of the implant will be placed 2 to 3 mm below CEJ of adjacent teeth. The surgical wound closure will be coapted with mattress and single interrupted sutures

10 Standard implants of length ≥ 10mm will be placed in augmented/native bone .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group - 18 years and above
• Presence of \>2 mm keratinised tissue to allow flap management.
• Systemically healthy patients
• The residual vertical bone height at the implant sites ranging from 6 to 9 mm for short implant placement ; \> 9 mm for standard implant placement.
• History of periodontitis

You may not qualify if:

• Medical conditions contraindicating surgical interventions
• Uncontrolled diabetes
• Hemorrhagic disorders
• Intravenous and oral bisphosphonate therapy.
• Irradiation in head and neck
• Pregnant and lactating women
• Subjects with known bone metabolic disorders (paget's disease , fibrous dysplasia etc.)
• Known smokers and alcoholics

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karantaka, 562157, India

Location

Related Publications (1)

• Esposito M, Barausse C, Pistilli R, Sammartino G, Grandi G, Felice P. Short implants versus bone augmentation for placing longer implants in atrophic maxillae: One-year post-loading results of a pilot randomised controlled trial. Eur J Oral Implantol. 2015 Autumn;8(3):257-68.

  PMID: 26355170 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)