Socket-Shield Technique With Immediate Implant

NCT05673122 | Unknown

• 1 other identifier: socket shield
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: Evaluate of labial plate of bone changes using immediate implant with the socket shield technique in anterior esthetic zone. Secondary Objective: Evaluate of soft tissue changes using the immediate implant with socket shield technique in anterior esthetic zone.

Conditions

Immediate Implants

Keywords

extraction socket; immediate implants; socket shield; labial bone thickness

Outcome Measures

Primary Outcomes (1)

• change of labial bone thickness

  With the help of CBCT ;Horizontal bone level measurement: Three horizontal lines are drawn 2, 4, and 6 mm apical to implant platform to outer surface of buccal plate of bone. Facial plate of bone is taken as a reference point and is measured baseline (after implant placement and at 6 months follow up).

  baseline at day of surgery and after 6 months

Secondary Outcomes (1)

• Pink esthetic score (PES)

  baseline presurgery and after 6 months

Study Arms (2)

Implant intact with shield

EXPERIMENTAL

Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, the implant is in contact with the shield.

Device: Implant(Flotecno)

Implant not intact with shield

EXPERIMENTAL

Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, there was a jumping gap more than 2mm between the shield and the implant, in which the gap was grafted with Xenograft.

Device: Implant(Flotecno)

Interventions

Implant(Flotecno) DEVICE

The implants It has a tapered body design and Sandblasting with Large grit that facilitates the osseointergration process. made in Italy Flotecno srl via.Turati,38 20121 MILANO (Italia)

Implant intact with shield; Implant not intact with shield

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Sufficient hard and soft tissue volume in vertical and buccolingual direction (Levine et al., 2014) 7. Good oral hygiene. 8. Indication for tooth extraction included :( Degidi et al., 2010)
• Non-restorable teeth
• Remaining roots
• Endodontic failures

You may not qualify if:

• \. Pregnant and breast feeding. 3. Smokers. (Takamiya et al., 2013) 4. Decision impaired individuals (prisoners, handicapped, and mentally retarded) 5. Vertical or Horizontal root fractures on buccal aspect below bone level. 6. External or internal root resorption.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Nasr City, 0020, Egypt

RECRUITING

Related Publications (10)

• Abdullah AH, Abdel Gaber HK, Adel-Khattab D. Evaluation of soft tissue and labial plate of bone stability with immediate implant in direct contact versus gap with socket shield: A randomized clinical trial with 1 year follow-up. Clin Implant Dent Relat Res. 2022 Oct;24(5):548-558. doi: 10.1111/cid.13117. Epub 2022 Jun 28.

  PMID: 35763398 BACKGROUND

• Degidi M, Daprile G, Piattelli A. Determination of primary stability: a comparison of the surgeon's perception and objective measurements. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):558-61.

  PMID: 20556255 BACKGROUND

• Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

  PMID: 16307569 BACKGROUND

• Salama M, Ishikawa T, Salama H, Funato A, Garber D. Advantages of the root submergence technique for pontic site development in esthetic implant therapy. Int J Periodontics Restorative Dent. 2007 Dec;27(6):521-7.

  PMID: 18092446 BACKGROUND

• Gluckman H, Nagy K, Du Toit J. Prosthetic management of implants placed with the socket-shield technique. J Prosthet Dent. 2019 Apr;121(4):581-585. doi: 10.1016/j.prosdent.2018.06.009. Epub 2018 Dec 13.

  PMID: 30554825 BACKGROUND

• Mourya A, Mishra SK, Gaddale R, Chowdhary R. Socket-shield technique for implant placement to stabilize the facial gingival and osseous architecture: A systematic review. J Investig Clin Dent. 2019 Nov;10(4):e12449. doi: 10.1111/jicd.12449. Epub 2019 Aug 21.

  PMID: 31433130 BACKGROUND

• Lin X, Gao Y, Ding X, Zheng X. Socket shield technique: A systemic review and meta-analysis. J Prosthodont Res. 2022 Apr 27;66(2):226-235. doi: 10.2186/jpr.JPR_D_20_00262. Epub 2021 Sep 16.

  PMID: 34526435 BACKGROUND

• Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.

  PMID: 22211305 BACKGROUND

• Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.

  PMID: 20712701 BACKGROUND

• Vittorini Orgeas G, Clementini M, De Risi V, de Sanctis M. Surgical techniques for alveolar socket preservation: a systematic review. Int J Oral Maxillofac Implants. 2013 Jul-Aug;28(4):1049-61. doi: 10.11607/jomi.2670.

  PMID: 23869363 BACKGROUND

Study Officials

• Ahmed A Hassan, Prof.Dr

  Ain Shams University

  STUDY CHAIR

• Asrar M Althabet, MSC

  Faculty of dentistry Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed W Bissar, Ass.Prof

CONTACT

00201006687399; Mohamedbissar_1@yahoo.com

Mohamed Sh El-Mofty, Prof.Dr

CONTACT

00201001431000; Mofty@dr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients were assigned in two allocated groups using computer randomization "random allocation software" into one of the 2 groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Model Details: Twenty patients were randomly assigned by specific computer software into two groups either in group (I) or group (II). Group I: Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, the implant is in contact with the shield. Group II: Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, there was a jumping gap more than 2mm between the shield and the implant, in which the gap was grafted with Xenograft.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 6, 2023
• Study Start: June 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

EG (1)