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Active, not recruitingNCT06700486Updated Nov 22, 2024

Assessment of the Socket Shield Technique Accompanied by Sticky Bone Around the Immediate Implant

An interventional study of SOCKET SHIELD and Immediate implant and sticky bone in Immediate Implant, sponsored by Reham Qabeel. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Reham Qabeel · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

challenge of the implant of esthetic zone with buccal plate of bone width less than 2mm become available by the using of socket shield technique used with the immediate implant this technique provide improvement of the width of buccal plate of bone which improve esthetic outcome bot the jumping gape still a questionable area between the shield and the implant which required to be filled with biological filling to improve osteointegration and stability of the implant such as sticky bone ,bone mixed with injectable PRF , PRF also has antibacterial ,anti-inflammatory effect and regenerative effect which could help.

Read the detailed description

Biological mechanisms involved in the healing of the periodontal tissues after tooth extraction can cause the loss of the periodontal ligament and its vascular support. The physiological process can lead to esthetic problems that are difficult to resolve by methods of restoration that are able to preserve the emergence profile, especially in the anterior region . Therefore, preserving and maintaining the bone anatomy and soft tissue architecture in the anterior region is essential for maintaining esthetics restorations .

Teeth extractions basis volumetric changes characterized by alveolar bone resorption, specifically the buccal plate of bone, with a consequential associated soft tissue retraction . Several studies proved that buccal dimension of the alveolar ridge undergoes horizontal bone resorption of about 56% and a resorption of the palatal /lingual bone of 30% through the interval four-month prior extraction of the tooth. Correspondingly . detected overall horizontal dimension resorption of the alveolar ridge subsequent the extraction, and the buccal wall reduction of the alveolar ridge is more obvious than lingual wall .

Immediate placement of implant does not totally overcome the resorption of the alveolar bone and recession of the soft tissue in esthetic region following teeth extractions. Loss of alveolar bone prior extraction consider as irreversible process concerning both vertical and horizontal resorption. Moreover, the alveolar bone resorption is more distinct on the buccal wall than on the lingual wall of the extraction socket.

The ridge dimension is reduced when implants are placed immediately without subsequent directed bone regeneration treatments. When compared to spontaneous healing, it appears to be ineffective at around half of the initial bone width in horizontal dimension . By using a grafting substance and combining instantaneous implant insertion with a guided bone-regeneration process, less horizontal bone resorption can be expected .

Several augmentation techniques are used in the surgical field to create sufficient bone volume. Grafting techniques for particulate bone augmentation include autograft, allograft, xenograft, and alloplast. Autograft is the gold standard in bone augmentation, but it has drawbacks such as second surgical-site morbidity and insufficient bone volume. Secondary infections are a disadvantage of allografts and xenografts Since 2010, a novel method of producing growth factor-enriched bone graft matrix (also known as sticky bone) with autologous fibrin glue has been demonstrated. Sticky bone stabilizes the bone graft in the defect, accelerating tissue healing and minimizing bone loss during the healing period. It is moldable and adaptable to a variety of bony defects, preventing micro and macro movement of the grafted bone. As a result, the volume of the augmentation is maintained during the healing process, and the need of titanium mesh and bone block is reduced .

In contrast to PRP or PRGF, the fibrin network entraps platelets and leukocytes to release growth factors, speeding up soft tissue regeneration and bone regeneration. Furthermore, unlike PRP or PRGF, no biochemical additives are required to make sticky bone, and fibrin interconnection reduces soft tissue ingrowth into the sticky bone graft .

Studies revealed that the presence of vascular supply from the periodontal ligament was a major factor in the preservation of alveolar bone and soft tissues, the idea of leaving the leftover root section on the labial plate was advocated. This procedure is known as "socket shield technology" in which the root fragment acts as a shield to protect the buccal bone from resorption

02

Conditions studied

  • Immediate Implant

Keywords

  • socket shield
  • sticky bone
03

In context

Lead sponsor

This is the only study on the registry with Reham Qabeel as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Patients having at least single tooth into esthetic zone indicated for extraction and immediate implant placement.
  1. patient with adequate oral hygiene and systemically free. 3.patients' age ranging from 20-60 years. 4. Free from any systemic disease according to Cornell Medical Index

Exclusion criteria

Exclusion Criteria:

    1. Presence of para-functional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.

      1. Chronic smokers or formal smoker. 3.Insulin dependent diabetes 4.Thyroid disease 5.Clinical diagnosis of Alzheimer's Disease 6. patients receiving chemotherapy or radiotherapy, alcohol or drug abuse 7. Pregnancy and lactation.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    comparator arm

    Immediate implant and sticky bone

    Procedure: SOCKET SHIELD

  • Other
    interventional arm

    Socket shield

    Procedure: Immediate implant and sticky bone

Interventions

  • ProcedureSOCKET SHIELD

    in implant dentistry

  • ProcedureImmediate implant and sticky bone

    in implant dentistry

06

What researchers measure

Primary outcomes

  1. Soft tissue thickness

    measured with mm

    Time frame: 6 months

  2. Marginal bone loss

    measured with mm

    Time frame: 9 months

Secondary outcomes

  1. Buccal bone width

    width measured with mm

    Time frame: 6 and 9 months

  2. Buccal bone length

    length measured with mm

    Time frame: 6 and 9 months

  3. Bone density

    Bone density measured with Hounsfield index

    Time frame: 6 and 9 months

07

Study locations

1 site
  • Reham Abdel Hady Ali Kabeel
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06700486
Lead sponsor
Reham Qabeel
Responsible party
Reham Qabeel (Assistant lecturer, Al-Azhar University) — Sponsor-investigator
First posted
Nov 22, 2024
Start date
Mar 12, 2023
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Nov 22, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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