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

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ClinicalTrials.gov Identifier: NCT03684356
Recruitment Status : Unknown
Verified February 2020 by Mohamed Atef Abd El Moneium, Cairo University.
Recruitment status was:  Recruiting
First Posted : September 25, 2018
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Atef Abd El Moneium, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Socket Shield Procedure: socket shield technique Procedure: xenograft Phase 3

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental
immediate implant with socket shield technique
 Procedure: socket shield technique
immediate implant placement with buccal part of the root is retained
Active Comparator: control
immediate implant placement with filling the buccal gap with xenograft
 Procedure: xenograft
immediate implant placement with filling the buccal gap with xenograft


Outcome Measures
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Primary Outcome Measures :
  1. pink esthetic score [ Time Frame: 9 months ]
    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


Secondary Outcome Measures :
  1. Recession of the buccal peri-implant mucosa [ Time Frame: 9 months ]
    measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins.

  2. Corono-apical peri-implant bone dimensional changes [ Time Frame: 6 months ]
    measured at the middle of the buccal implant surface after the superimposition of Cone Beam C.T scans as the difference between the former and new vertical distance from the implant platform to the buccal alveolar crest

  3. Bucco-lingual peri-implant bone dimensional changes [ Time Frame: 6 months ]
    measured at middle of the buccal implant surface 1mm below the alveolar crest after the superimposition of the Cone Beam C.T scans as the difference between the former and new horizontal distance between the buccal and the palatal plate of bone

  4. Patient satisfaction: VAS [ Time Frame: 9 months ]
    Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled "much less than natural teeth" which is marked by zero and the left anchor labeled "much more" which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684356


Contacts
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Contact: Mohamed A Abd El Moneium, Ass.lecturer 01224302609 ext 002 matef1989@gmail.com
Contact: Ahmed H El Barbary, A. professor 01223153678 ext 002 ahmedelbarbary102@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 141
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Amr F Zahran, Professor Professor in Department of Oral Medicine and Periodontology
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mohamed Atef Abd El Moneium, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03684356    
Other Study ID Numbers: CairoU12
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No