Elamrousy's Novel Approach to Socket Shield Technique

NCT06263842 | Completed

• 1 other identifier: KFSIRB200-132
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft. The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.

Conditions

Implant Complication

Outcome Measures

Primary Outcomes (3)

• Stability Quotient of dental implant (SQDI)

  Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means \>70 ISQ, between 60-69 is medium stability and \< 60 ISQ is considered as low stability.

  24-month.

• pink esthetic score (PES)

  The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14

  24-month.

• Midfacial Mucosal Alterations

  digital intraoral scans were recorded. To quantify the vertical changes in the soft tissues around implants buccally, the collected scans were digitally superimposed via matching Gom inspect software

  24-month.

Secondary Outcomes (1)

• facial marginal bone level (FMBL)

  24-month.

Study Arms (3)

Immediate Implant Placement Using Socket Shield Technique alone

EXPERIMENTAL

after insertion of immediate implant Using Socket Shield Technique, the bone defect between the socket shield and the implant fixture will be left ungrafted

Procedure: conventional socket shield

Immediate Implant Placement Using Socket Shield Technique with xenograft

EXPERIMENTAL

the shield/fixture jumping gap will be grafted with xenograft

Procedure: combined socket shild with xenograft

Modified Elamrousy Approach for Immediate Implant Placement Using Socket Shield Technique

EXPERIMENTAL

Immediate Implant Placement Using Socket Shield Technique with autogenous whole tooth graft after immediate implantation using Socket Shield Technique, the palatal root portion and the decoronated crown will be converted to autogenous whole tooth graft and used for grafting the defect between the socket shield and the implant fixture

Procedure: modified Elamrousy approach for socket shield technique

Interventions

conventional socket shield PROCEDURE

the jumping gap will be left ungrafted

Immediate Implant Placement Using Socket Shield Technique alone

combined socket shild with xenograft PROCEDURE

the jumping gap will be filled with xenograft

Immediate Implant Placement Using Socket Shield Technique with xenograft

modified Elamrousy approach for socket shield technique PROCEDURE

the jumping gap will be filled with AWTG

Modified Elamrousy Approach for Immediate Implant Placement Using Socket Shield Technique

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• above the age of 18years
• presence of non-restorable maxillary anterior tooth
• had sufficient bone volume and
• The primary stability at insertion not less than 35 N

You may not qualify if:

• history of systemic condition
• history of using bisphosphonates or other drugs that might impact bone turnover
• a history of smoking during the previous five years,
• a history of any acute infections at the surgical site,
• teeth having root resorptions
• massive periodontal destruction
• , the presence of any systemic diseases;
• intake of drugs that may alter bone metabolism
• presence of acute infection
• infra-bony horizontal tooth fracture
• facial vertical root fracture;
• root resorption; mobile teeth
• malaligned teeth,
• active periodontitis at the implantation site.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Walid Elamrousy

Kafr ash Shaykh, 76130, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics; Transplantation

Study Officials

• Walid AH Elamrousy, PhD

  Faculty of Oral and Dental Medicine, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: neither participant nor the outcome assessor know the group distribution
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of periodontology

Model Details: The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using SSA protocol without grafting, while group II was grafted by xenograft, but group II was grafted with AWTG was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT).

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 16, 2024
• Study Start: February 14, 2024
• Primary Completion: March 15, 2026
• Study Completion: March 19, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)