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Status unknownNCT04101552Updated Sep 24, 2019

Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites

An interventional study of socket shield technique with xenophobic graft particulate and without the use of graft in Fractured Tooth, sponsored by Cairo University. Status unknown. Per ClinicalTrials.gov, last updated 2019-09-24.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Sex
All
01

Study summary

Many techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions .

Immediate implant placement, flapless implant placement, palataly positioned implants and even platform switching.

However none of these methods were able to completely preserve the coronal part of the facial bone wall, and since the main reason of bone loss following extraction is the loss of the periodontal ligament, it seemed logical that root retention may affect the resorption process,The reason the root retention technique works in its different applications is due to the maintenance of the periodontal attachment including cementum, periodontal ligaments and bundle bone, this principle was used by Hurzeler in 2010 in a technique called socket shied technique.

Read the detailed description
  • The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional immediate implant placement with immediate temporization and study group socket shield technique with immediate temporization.
  • Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
  • Intra operative procedures (for both groups) followed by CBCT will be taken for every patient
  • Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • In the study group: along surgical fissure bur will be used for hemisectioning.
  • The palatal portion will be carefully separated and extracted by a periotome and forceps.
  • The osteomy site will be inspected and cleaned from any granulation tissue and the implant will be placed palatal to the tooth fragment.
  • The jump gap was grafted with a xenogeneic bone particulate (De-proteinized bovine bone mineral Small granules (0.25-1 mm), the implant gained primary stability from bone apical and palatal sufficient to immediately restore with provisional restoration.
  • In the control group: the root was hemisected using a fissure bur in a mesio-distal direction, and a traumatic removal of the palatal fragment of the root was achieved (no pressure was applied on it), then the buccal fragment was reduced using surgical bur leaving a thin layer of the root aspect intact to the buccal plate of the bone.
  • The implant is placed in the socket in a way leaving space away from the remaining buccal plate without grafting this jumping gap
  • The provisional restorations were relieved of occlusal contacts in centric occlusion and excursive movements. These restorations remained in situ for at least 6 to 12 weeks prior to any modifications or commencement of definitive restorative therapy
  • A soft diet was recommended for the duration of the implant-healing phase. The patient was advised against functioning or activities to the implant site.
02

Conditions studied

  • Fractured Tooth

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03

In context

Tooth Fractures

35 studies on the registry are indexed under Tooth Fractures; 7 are open to participants now.

This study's planned enrollment of 10 is below the median of 40 across 31 interventional studies indexed under Tooth Fractures.

Browse Tooth Fractures studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

Exclusion criteria

Exclusion Criteria:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Uncontrolled diabetic patients.
  • Pregnant patients.
  • Teeth with Large pulpal pathosis as cysts, large periapical granulomas
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
  • Psychiatric problems.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    grafted versus graft less socket shield technique

    Procedure: socket shield technique with xenophobic graft particulate and without the use of graft

Interventions

  • Proceduresocket shield technique with xenophobic graft particulate and without the use of graft

    the jumping gap between the implant and the shield is grafted by xenograft particulate and the control group is not grafted

06

What researchers measure

Primary outcomes

  1. Marginal bone loss

    Will be measured using linear measurements from CBCT

    Time frame: • Amount of bone loss will be measured after 6 month using linear measurement from CBCT

Secondary outcomes

  1. secondary stability

    Will be measured using Osstell

    Time frame: will be measured intraoperative and 3 months after surgery

Other outcomes

  1. pink esthetic score

    Will be measured using pink esthetic index chart

    Time frame: Pink esthetics will be measured using pink esthetic index chart After 6 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04101552
Lead sponsor
Cairo University
Responsible party
Poosy Hany Zaki Mohamed (principal investigator, Cairo University) — Principal investigator
First posted
Sep 24, 2019
Start date
Sep 20, 2019 (estimated)
Primary completion
Feb 20, 2020 (estimated)
Completion
Aug 20, 2020 (estimated)
Last update
Sep 24, 2019

Study contacts

Poosy H. Mohamed, principal investigator
Contact
pussy_hany@yahoo.com
01098008064 ext. 00202
Mohamed A. Abdelrasoul, lecturer
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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