Elamrousy Modified Approach for Socket Shield Technique

NCT06043037 | Completed DMC

• 1 other identifier: KFSIRB200-82
• Study Type: interventional
• Target: 50
• 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 demineralized dentin graft (ADDG) with socket shield technique (SST) and compared this approach to socket shield technique (SST) alone. The present study included 50 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, participants were randomized into 2 groups: the control group patients underwent immediate implantation using SS protocol, while the study group patients underwent the same procedure, but ADDG was created using the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect.

Conditions

Dental Implant Failed; Implant Site Reaction; Tooth Extraction Status Nos

Outcome Measures

Primary Outcomes (1)

• crestal bone thickness

  Utilizing CBCT sagittal sections, the crestal bone thickness was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.

  30-month.

Secondary Outcomes (4)

• buccal marginal bone level (BMBL)

  24 months

• Midfacial Mucosal Alterations

  30months

• PES

  30months

• Implant Stability Quotient (ISQ)

  30months

Study Arms (2)

Immediate Implant Placement Using Socket Shield Technique with autogenous demineralized dentin graft

ACTIVE COMPARATOR

after immediate implantation using Socket Shield Technique, the palatal root portion will be converted to autogenous demineralized dentin graft and used for grafting the defect between the socket shield and the implant fixture

Procedure: Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Technique

Immediate Implant Placement Using Socket Shield Technique only without grafting the defect

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: Immediate Implant Placement Using Socket Shield Technique alone

Interventions

Immediate Implant Placement Using Socket Shield Technique alone PROCEDURE

The flapless strategy was used. To prepare the SS, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm.(12) The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap was left without grafts.

Immediate Implant Placement Using Socket Shield Technique only without grafting the defect

Elamrousy Novel Approach for Immediate Implant Placement Using Socket Shield Technique PROCEDURE

The flapless strategy was used. To prepare the SS, tooth decoronation followed by root splitting mesio-distally. The palatally splitted portion of the root is atraumatically extracted while the intact buccal root portion is kept in place with thickness of 1.5mm.(12) The implant fixture is then placed palatally with 2mm gap distance in between. finally, that gap was grafted with ADDG

Also known as: Immediate Implant Placement Using Socket Shield Technique grafted by autogenous demineralized dentin graft

Immediate Implant Placement Using Socket Shield Technique with autogenous demineralized dentin graft

Eligibility Criteria

• Age: 18 Years - 40 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 intact socket walls following tooth extraction
• the gingival biotype was thick.

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
• buccally fractured root either vertically or horizontally beneath the alveolar crest.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: neither participant nor the outcome assessor know the group districution
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of periodontology

Model Details: The present study included 50 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, participants were randomized into 2 groups: the control group patients underwent immediate implantation using SS protocol, while the study group patients underwent the same procedure, but ADDG was created using 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), implant stability quotient (ISQ) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal bone dimension (HBD), buccal marginal bone level (BMBL), peri-implant Bone Density (PIBD) and peri-implant vertical bone defect (PIVBD) changes were assessed using cone beam computed tomography (CBCT).

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: September 21, 2023
• Study Start: July 18, 2023
• Primary Completion: March 18, 2026
• Study Completion: March 21, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)