Immediate vs Delayed Loading of Single Tooth Implants

NCT03216122 | Completed DMC

• 1 other identifier: Subramony perio
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have shown high success rates of immediately loaded implants on par with conventionally loaded implants (DL), while a few studies have also reported failure rates. Various studies can be found in the English literature comparing IL to DL protocol, few of which used the flapless approach while few used cylindrical implants or were confined to maxillary anterior region. Furthermore, a perusal of literature revealed no study which used RVG for radiographic evaluation and evaluated the morbidity at the implant site in normal healthy adult population. Hence this study would help determine whether the IL protocol is on par with DL protocol, so as to reduce patient waiting time, prevent space closure and provide early patient satisfaction from an aesthetic stand point.

Conditions

Implant Complication

Outcome Measures

Primary Outcomes (1)

• Crestal bone loss

  Interproximal marginal bone loss

  7 months primary, total time frame 4 years

Study Arms (2)

Control group (CG)

ACTIVE COMPARATOR

The implant will be loaded after 3-4 months of placement (Conventional/Delayed Loading)

Procedure: Conventional/Delayed Loading

Test group (TG)

ACTIVE COMPARATOR

The implant will be loaded non-occlusally within 3-4 days of placement (Immediate Loading)

Procedure: Immediate Loading

Interventions

Conventional/Delayed Loading PROCEDURE

Control group (CG)

Immediate Loading PROCEDURE

Test group (TG)

Eligibility Criteria

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

You may qualify if:

• Patient having minimum single tooth edentulous space.
• Adequate bone quality and quantity at the implant site.
• Patient with acceptable oral hygiene (Plaque index\<1.5).

You may not qualify if:

• Medically compromised patient or patient taking immunosuppressive drugs or bisphosphonates which may complicate the treatment outcome.
• Infection at the implant site and adjacent site.
• History of bruxism or parafunctional habits.
• Patient having history of bleeding disorder or on anticoagulant therapy.
• Chronic smoker and using tobacco in any form.
• Patients allergic to medication (Local anesthetic, Penicillin group of antibiotics, non- steroidal anti-inflammatory drugs) and implant.
• Pregnant or lactating females.
• Individuals with unacceptable oral hygiene (PI\>1.5).
• History of radiotherapy in the head and neck area

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Congresses as Topic; Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• SUBRAMONY BHAGAVATHEESWARAN

  PGIDS ROHTAK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: December 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IN (1)