Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone

• Sponsor: Egyptian Russian University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05409950
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Bone Resorption	Procedure: Immediate implant placement using socket shield technique	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
• Actual Study Start Date: Sep 16, 2019
• Actual Primary Completion Date: Jan 6, 2021
• Actual Study Completion Date: Sep 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study group: implants were inserted using socket shield technique at the esthetic zone	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
No Intervention: Control group: implants were inserted using conventional immediate technique

Outcome Measures

Primary Outcome Measures

1. Implant stability [immediate postoperative]

   Using osstell

2. Implant stability [one month post-operative]

   Using osstell

3. Implant stability [three month post-operative]

   Using osstell

4. Implant stability [six month post-operative]

   Using osstell

5. Horizontal gap [immediate postoperative]

   Using cone-beam computed tomography

6. Horizontal gap [six month post-operative]

   Using cone-beam computed tomography

7. Vertical bone loss [immediate postoperative]

   Using cone-beam computed tomography

8. Vertical bone loss [six month post-operative]

   Using cone-beam computed tomography

9. Bone density [immediate postoperative]

   Using cone-beam computed tomography

10. Bone density [six month post-operative]

    Using cone-beam computed tomography

11. peri-implant probing depth [immediate postoperative]

    using periodontal probe

12. peri-implant probing depth [one month post-operative]

    using periodontal probe

13. peri-implant probing depth [three month post-operative]

    using periodontal probe

14. peri-implant probing depth [six month post-operative]

    using periodontal probe

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suez canal university	Ismailia		Egypt

Sponsors and Collaborators

• Egyptian Russian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Egyptian Russian University
• ClinicalTrials.gov Identifier: NCT05409950
• Other Study ID Numbers: HR-1
• First Posted: Jun 8, 2022
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Egyptian Russian University: Immediate implants, sockets shield technique, esthetic zone
• Additional relevant MeSH terms: Bone Resorption

Study Results

No Results Posted as of Jun 8, 2022