Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure

NCT01399775 | Completed Phase 1 DMC

• 1 other identifier: 87703
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation
2. 2.evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability

Conditions

Atrophy of Edentulous Alveolar Ridge; Alveolar Ridge Augmentation

Keywords

Atrophy of Edentulous Alveolar Ridge; Dental Prosthesis, Implant-Supported; Dental Implants, Single-Tooth

Outcome Measures

Primary Outcomes (1)

• dimensional changes

  Horizontal dimensions (bucco-linguall) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.

  baseline to 3 months

Secondary Outcomes (1)

• implant stability

  baseline to 3 months

Study Arms (2)

immediate implantation

EXPERIMENTAL

Immediately after tooth extraction, dental implant is inserted.

Procedure: immediate implantation

Delayed implantation

OTHER

Four months after extraction, Dental implant is inserted.

Procedure: Delayed implantation

Interventions

immediate implantation PROCEDURE

Immediately after tooth extraction, a dental implant is inserted

Also known as: Implant in fresh socket

immediate implantation

Delayed implantation PROCEDURE

Four months after extraction, a dental implant is inserted and measurements are recorded.

Delayed implantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hopeless single root tooth and willing for dental implants
• Having no systemic disease

You may not qualify if:

• Fail to osseointegrate

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University of Medical Sciences, Dental school

Mashhad, Khorasan Razavi, 91735-984, Iran

Location

MeSH Terms

Interventions

Drug Implants; Embryo Implantation, Delayed

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Embryo Implantation; Embryonic Development; Embryonic and Fetal Development; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Mehrdad Radvar, DDS., Phd

  Mashhad University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of periodontics

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 22, 2011
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

IR (1)