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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05409950
Other study ID # HR-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2019
Est. completion date September 7, 2021

Study information

Verified date June 2022
Source Egyptian Russian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was conducted on 20 immediate implant placement sites in the anterior maxillary region. In the study group, 10 implants were inserted using socket shield technique, while in control group, 10 implants were inserted using conventional immediate placement technique. All patients received immediate and 6 months post-operative CBCT to assess horizontal bone loss, vertical bone loss, and measurement of bone density. Implant stability quotients (ISQs) was measured immediately, 1st, 3rd and 6 months post-operatively.


Description:

Unrestorable tooth extraction with immediate implant placement is considered one of the best treatment options in restoring the esthetics and function. Extraction socket resorption is considered a challenging procedure when it involves the esthetics zone. The preservation of the entire attachment apparatus for complete preservation of the alveolar ridge makes socket shield technique a promising procedure that helps to maintain anatomy, esthetics and function. Socket shield technique, eliminate the negative consequences of bone resorption of the buccal plate of bone; leading to maintaining hard and soft tissue contours and provides a perfect pleasing esthetic result with good function. It is a highly promising technique in terms of maintaining pink and white esthetics through preservation of the interdental papilla during preparation of the interdental socket shield. It is considered a minimally invasive surgical procedure and offers the advantages of immediate implant placement.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 7, 2021
Est. primary completion date January 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: 1. Endodontic or non-endodontic treated un-restorable remaining root/ tooth related to maxillary anterior teeth. 2. Healthy adult patients > 20 years old (ASAI, II) . 3. Adequate oral hygiene. 4. Intact periodontal tissues. Exclusion Criteria: 1. Periapical or periodontal active infection involving the teeth/root to be extracted (as excluded by radiographic examination). 2. Medically compromised patients (ASA III, IV, V). 3. Patients receiving chemotherapy or radiotherapy. 4. Heavy smokers,alcohol or drug abuse. 5. Patients with parafunctional habits such as bruxism, clenching, excessive gum chewing, lip or fingernail biting.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Immediate implant placement using socket shield technique
Evaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement

Locations

Country Name City State
Egypt Suez canal university Ismailia

Sponsors (1)

Lead Sponsor Collaborator
Egyptian Russian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implant stability Using osstell immediate postoperative
Primary Implant stability Using osstell one month post-operative
Primary Implant stability Using osstell three month post-operative
Primary Implant stability Using osstell six month post-operative
Primary Horizontal gap Using cone-beam computed tomography immediate postoperative
Primary Horizontal gap Using cone-beam computed tomography six month post-operative
Primary Vertical bone loss Using cone-beam computed tomography immediate postoperative
Primary Vertical bone loss Using cone-beam computed tomography six month post-operative
Primary Bone density Using cone-beam computed tomography immediate postoperative
Primary Bone density Using cone-beam computed tomography six month post-operative
Primary peri-implant probing depth using periodontal probe immediate postoperative
Primary peri-implant probing depth using periodontal probe one month post-operative
Primary peri-implant probing depth using periodontal probe three month post-operative
Primary peri-implant probing depth using periodontal probe six month post-operative
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