Elamrousy Novel Approach of Socket Shield Technique

Peri-implant Clinical and Radiographic Alterations Following Immediately Placed, Immediately Loaded Dental Implants Using Socket Shield Approach With Autogenous Whole Tooth Graft Versus Xenograft: Randomized Clinical Tial

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.

Study Overview

• Status: Recruiting
• Conditions: Implant Complication
• Intervention / Treatment: Procedure: conventional socket shield; Procedure: combined socket shild with xenograft; Procedure: modified Elamrousy approach for socket shield technique

Detailed Description

It has been demonstrated that utilizing dental implants to replace lost teeth is a predictable clinical choice. Promising outcomes of immediate implant insertion in conjunction with immediate loading/provisionalization (Type 1A implant protocol according to Gallucci et al has been reported to provide major benefits in terms of better esthetic and psychosocial impacts, shorter treatment duration, minimal surgical interventions and preservation of peri-implant bone and soft tissue.

However, because of technically sensitive and sophisticated surgery required for Type 1A protocol, high risk of early implant failure was noticed particularly in conditions that might complicate that protocol as deficient facial bone plate, soft tissues deficiencies and thin gingival phenotype. Furthermore, those conditions also were found to be responsible for midfacial mucosal recession (MFMR), papillary recession and resorption of facial plate that deteriorates the clinical, radiological, and esthetic outcomes of Type 1A protocol. Consequently, alternate approaches would be suggested to improve the clinical and esthetic concerns associated with immediate implantation and loading such as buccal gap grafting, guided bone regeneration and socket shield approach.

In order to maintain the facial bone plate for prompt Type 1A protocol in esthetic zone, the SSA has been developed by Hürzeler et al. in 2010 as a potential therapeutic approach through maintaining the facial portion of the root and thus preserving the periodontal ligament and its vascularity that nourishes the tooth's bundle bone. The FSS functions as a natural barrier that prevents buccal bone resorption and enhances tissue contouring, both of which contribute to the achievement of predictable esthetic outcomes. Additionally, the FSS serves as a guide to ensure the implant is positioned correctly. SSA in conjunction with immediate loading reduces the frequency of clinical sessions and reduces the necessity for both soft and hard tissue grafts.

It has been recommended to palatally insert the implants in extraction sockets with at least 2 mm jumping gap between the fixture and the FSS. Significantly, this gap denotes the future buccal bone that will directly contribute to the buccal contour and impact the soft tissue levels. For jumping gaps smaller than 2 mm, bone heals spontaneously, while gaps bigger than 2 mm are advised to be augmented.

AWTG is obviously very advantageous as it exhibits superior osteoconductive and osteoinductive capacity with high biocompatibility and comparable physico-chemical characteristics to autogenous bones. AWTG was successfully employed for augmenting of peri-implant bone defects, with excellent clinical and radiographic outcomes. Similarly, both AWTG and autogenous demineralized dentin graft were equally effective at reducing dimensional losses in alveolar ridge preservation. The production of demineralized dentin is time-consuming, cost-intensive and complicated, which restricts its widespread use in clinics.

In the light of this, the current study was conducted to assess and compare the effectiveness of AWTG versus xenograft for augmenting the FSS/fixture jumping gap around immediately placed implants using SSA with immediate temporization in the maxillary esthetic zone.

To the best of our knowledge, this study is the first to use AWTG for filling the peri-implant jumping gap following SSA and highlight its impact on peri-implant soft and hard tissue parameters compared to xenograft.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walid AH Elamrousy, PhD; Phone Number: +201091444946; Email: waled_hammed@den.kfs.edu.eg

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 76130
    • Recruiting
    • Walid Elamrousy
    • Contact: walid elamrousy, phd; Phone Number: +201005724781; Email: Waled_Hammed@den.kfs.edu.eg
    • Contact: mostafa fayed, bachelor; Phone Number: +201063376252

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• above the age of 18years
• presence of non-restorable maxillary anterior tooth
• had intact socket walls following tooth extraction
• the gingival biotype was thick.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Implant Placement Using Socket Shield Technique alone; 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; the jumping gap will be left ungrafted
Experimental: Immediate Implant Placement Using Socket Shield Technique with xenograft; the shield/fixture jumping gap will be grafted with xenograft	Procedure: combined socket shild with xenograft; the jumping gap will be filled with xenograft
Experimental: Modified Elamrousy Approach for Immediate Implant Placement Using Socket Shield Technique; 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; the jumping gap will be filled with AWTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12-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	12-month.
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.	12-month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
facial marginal bone level (FMBL)	Utilizing CBCT sagittal sections, the BMBL 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.	12-month.

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2024
• Primary Completion (Estimated): February 10, 2025
• Study Completion (Estimated): February 20, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KFSIRB200-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No