Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets. (RCT)

July 8, 2019 updated by: Andrew George Edward Aziz, Cairo University
The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Atraumatic extraction is done and the socket is either left for spontaneous healing or the ice cream cone technique using the collagen membrane and the socket is filled with xenograft.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single or double rooted teeth indicated for extraction
  • Presence of a buccal defect.
  • Maxillary and Mandibular Arches

Exclusion Criteria:

  • Systemic conditions/disease that contraindicated surgery.
  • Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
  • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
  • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ice Cream Cone Technique
Atraumatic extraction followed by addition of barrier membrane and xenograft in the socket.
Procedure: Ice Cream Cone Technique
Guided bone regeneration
No Intervention: Spontaneous Healing
Spontaneous Healing after Atraumatic Extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal Bone Dimension from the CBCT in mm.
Time Frame: 3 months
from the CBCT in mm.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buccal Vertical Bone Dimension
Time Frame: 3 months
from CBCT in mm.
3 months
Palatal Vertical Bone Dimension
Time Frame: 3 months
from CBCT in mm.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Philo new protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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