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Completed

NCT Number: NCT05047887

Socket Preservation Using Socket Shield Technique Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material

Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with autogenous dentine was introduced to preserve the periodontal ligaments.

this study aim to evaluate of socket preservation using alloplast with socket shield versus Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone dimension change and mean bone density in addition to histological and histomorphometric analysis for the quality of the formed bone.

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Key information

Conditions

Extraction Tooth Socket

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • One or more of non-restorable (fractured or decayed) tooth/teeth in the maxillary aesthetic regions (incisors, premolars) in both side
  • Intact labial periodontal tissues.
  • Ability to read and sign an informed consent form.

Exclusion criteria

  • A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
  • Untreated periodontal disease.
  • Vertical root fractures on the labial aspect.
  • Tooth /teeth with horizontal fractures below bone level.
  • Tooth /teeth with external or internal resorptions.

Treatment and study plan

Modified socket shield technique with autogenous dentin graft material (in one side)

Procedure

The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then Tooth particles will be demineralized using 2% HNO3 (El-Gomhouria CO. Egypt) for 20 minutes to expose the dentin organic matrix.

Modified socket shield technique with alloplast graft material (in contralateral side)

Procedure

The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then alloplast graft will be used

Primary outcomes

  1. post opertaive edema

    Time frame: after 7 days

    This will be assessed in the 1st week postoperatively and measured as follows: None (no inflammation) Mild (intraoral swelling confined to the surgical field) Moderate (extraoral swelling in the surgical zone) Severe (extraoral swelling spreading beyond the surgical zone).

  2. change in pain score

    Time frame: 1 week and 3 months

    it will be assessed using VAS It rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain

  3. Change in bone density

    Time frame: at baseline and 3 months

    it will be assessed using CBCT

  4. Change in bone height

    Time frame: at baseline and 3 months

    it will be assessed using CBCT

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material (Clinical and Histological Study)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2021
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.