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

Phase 3

• Conditions: Socket Shield
• Interventions: Procedure: socket shield technique; Procedure: xenograft

• Registration Number: NCT03684356
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2019-02-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-18
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	socket shield technique	immediate implant with socket shield technique
control	xenograft	immediate implant placement with filling the buccal gap with xenograft

Primary Outcome Measures

Name	Time	Method
pink esthetic score	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

Name	Time	Method
Corono-apical peri-implant bone dimensional changes	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
Bucco-lingual peri-implant bone dimensional changes	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
Recession of the buccal peri-implant mucosa	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.
Patient satisfaction: VAS	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt