NCT03684356

Brief Summary

The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.

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
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 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

September 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 22, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

September 24, 2018

Last Update Submit

February 17, 2020

Conditions

Socket Shield

Outcome Measures

Primary Outcomes (1)

  • pink esthetic score

    Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral

    9 months

Secondary Outcomes (4)

  • Recession of the buccal peri-implant mucosa

    9 months

  • Corono-apical peri-implant bone dimensional changes

    6 months

  • Bucco-lingual peri-implant bone dimensional changes

    6 months

  • Patient satisfaction: VAS

    9 months

Study Arms (2)

experimental

EXPERIMENTAL

immediate implant with socket shield technique

Procedure: socket shield technique

control

ACTIVE COMPARATOR

immediate implant placement with filling the buccal gap with xenograft

Procedure: xenograft

Interventions

socket shield techniquePROCEDURE

immediate implant placement with buccal part of the root is retained

experimental
xenograftPROCEDURE

immediate implant placement with filling the buccal gap with xenograft

control

Eligibility Criteria

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

You may qualify if:

  • Patient's age was 18 years or older.
  • Non-restorable tooth in the upper inter-bicuspid area.
  • Adequate bone volume for the placement of immediate implant.
  • Following tooth extraction, there was an intact socket bony wall (type I extraction socket).
  • Primary stability of the implant was achieved at the time of the implant placement.

You may not qualify if:

  • Patients who reported tobacco use in the past 5 years.
  • Patients who had severe periodontal destruction at the site of implant placement.
  • The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth.
  • Patients who had history of any systemic disease that precludes the placement of implants.
  • Any disease that might affect bone metabolism as osteoporosis.
  • Patients taking medications that might affect bone turn over as bisphosphonates.
  • Physically or mentally handicapped patients.
  • Pregnant females.
  • Teeth with vertical root fractures on the buccal aspect
  • Teeth with any other pathologies affecting the buccal part of the root, for example, external or internal resorptions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 141, Egypt

RECRUITING

Related Publications (6)

  • Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.

    PMID: 28333394BACKGROUND

  • Bramanti E, Norcia A, Cicciu M, Matacena G, Cervino G, Troiano G, Zhurakivska K, Laino L. Postextraction Dental Implant in the Aesthetic Zone, Socket Shield Technique Versus Conventional Protocol. J Craniofac Surg. 2018 Jun;29(4):1037-1041. doi: 10.1097/SCS.0000000000004419.

    PMID: 29489581BACKGROUND

  • Mitsias ME, Siormpas KD, Kotsakis GA, Ganz SD, Mangano C, Iezzi G. The Root Membrane Technique: Human Histologic Evidence after Five Years of Function. Biomed Res Int. 2017;2017:7269467. doi: 10.1155/2017/7269467. Epub 2017 Nov 22.

    PMID: 29333449BACKGROUND

  • Siormpas KD, Mitsias ME, Kontsiotou-Siormpa E, Garber D, Kotsakis GA. Immediate implant placement in the esthetic zone utilizing the "root-membrane" technique: clinical results up to 5 years postloading. Int J Oral Maxillofac Implants. 2014 Nov-Dec;29(6):1397-405. doi: 10.11607/jomi.3707. Epub 2014 Sep 26.

    PMID: 25265125BACKGROUND

  • Tan Z, Kang J, Liu W, Wang H. The effect of the heights and thicknesses of the remaining root segments on buccal bone resorption in the socket-shield technique: An experimental study in dogs. Clin Implant Dent Relat Res. 2018 Jun;20(3):352-359. doi: 10.1111/cid.12588. Epub 2018 Feb 8.

    PMID: 29417708BACKGROUND

  • Atef M, El Barbary A, Dahrous MSE, Zahran AF. Comparison of the soft and hard peri-implant tissue dimensional changes around single immediate implants in the esthetic zone with socket shield technique versus using xenograft: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2021 Jun;23(3):456-465. doi: 10.1111/cid.13008. Epub 2021 May 24.

    PMID: 34028974DERIVED

MeSH Terms

Interventions

Immediate Dental Implant LoadingTransplantation, Heterologous

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodonticsTransplantation

Study Officials

  • Amr F Zahran, Professor

    Professor in Department of Oral Medicine and Periodontology

    STUDY CHAIR

Central Study Contacts

Mohamed A Abd El Moneium, Ass.lecturer

CONTACT

01224302609matef1989@gmail.com

Ahmed H El Barbary, A. professor

CONTACT

01223153678ahmedelbarbary102@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 25, 2018

Study Start

February 22, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)