Comparison of Peri-implant Tissues Using Socket Shield Technique Versus Xenograft

NCT ID: NCT03684356

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft.

* Population (P): Patients with single non-restorable tooth in the esthetic zone.
* Intervention (I): Immediate implant placement with socket shield technique.
* Comparator (C): Immediate implant placement and filling the buccal gap with xenograft.
* Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005).
* Time frame: 9 months (Chu et al., 2015).
* Study design: Randomized controlled clinical trial.

Conditions

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Socket Shield

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experimental

immediate implant with socket shield technique

Group Type EXPERIMENTAL

socket shield technique

Intervention Type PROCEDURE

immediate implant placement with buccal part of the root is retained

control

immediate implant placement with filling the buccal gap with xenograft

Group Type ACTIVE_COMPARATOR

xenograft

Intervention Type PROCEDURE

immediate implant placement with filling the buccal gap with xenograft

Interventions

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socket shield technique

immediate implant placement with buccal part of the root is retained

Intervention Type PROCEDURE

xenograft

immediate implant placement with filling the buccal gap with xenograft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Atef Abd El Moneium

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr F Zahran, Professor

Role: STUDY_CHAIR

Professor in Department of Oral Medicine and Periodontology

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed A Abd El Moneium, Ass.lecturer

Role: CONTACT

01224302609 ext. 002

Ahmed H El Barbary, A. professor

Role: CONTACT

01223153678 ext. 002

References

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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.

Reference Type BACKGROUND
PMID: 28333394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29489581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29333449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25265125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29417708 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34028974 (View on PubMed)

Other Identifiers

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CairoU12

Identifier Type: -

Identifier Source: org_study_id

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