NCT04013425

Brief Summary

The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 7, 2019

Last Update Submit

July 8, 2019

Conditions

Socket Preservation

Keywords

Socket preservationAlveolar Ridge PreservationRidge Preservation

Outcome Measures

Primary Outcomes (1)

  • Horizontal Bone Dimension from the CBCT in mm.

    from the CBCT in mm.

    3 months

Secondary Outcomes (2)

  • Buccal Vertical Bone Dimension

    3 months

  • Palatal Vertical Bone Dimension

    3 months

Study Arms (2)

Ice Cream Cone Technique

EXPERIMENTAL

Atraumatic extraction followed by addition of barrier membrane and xenograft in the socket.

Procedure: Ice Cream Cone Technique

Spontaneous Healing

NO INTERVENTION

Spontaneous Healing after Atraumatic Extraction

Interventions

Ice Cream Cone TechniquePROCEDURE

Guided bone regeneration

Ice Cream Cone Technique

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrew George

Cairo, 11451, Egypt

RECRUITING

Related Publications (1)

  • Tan-Chu JH, Tuminelli FJ, Kurtz KS, Tarnow DP. Analysis of buccolingual dimensional changes of the extraction socket using the "ice cream cone" flapless grafting technique. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):399-403. doi: 10.11607/prd.1605.

    PMID: 24804291RESULT

Central Study Contacts

Andrew George

CONTACT

+201270151119drewgeorge90@gmail.com

Sandy Samaan

CONTACT

+201229697114sandy-samir@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 7, 2019

First Posted

July 9, 2019

Study Start

August 1, 2019

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

EG(1)