Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques

NCT04803110 | Active Not Recruiting

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

Brief Summary

The aim is to comparatively evaluate the soft tissue volume changes that occur after tooth extraction and immediate dental implant placement using two different surgical techniques. These techniques are: the Socket-Shield technique and conventional immediate placement. The null hypothesis is that the Socket-Shield technique better maintains soft tissue volume after partial tooth extraction and immediate implant placement compared to the conventional technique. From a sample of 20 patients, they will be divided into groups of 10 and will be randomized using the random.org program. The soft tissue volume will be digitally recorded by intraoral scanning before tooth extraction and 6 months later. The soft tissue dimensional changes produced will be digitally evaluated and statistically analyzed.

Conditions

Dental Implant; Tooth Extraction; Bone Resorption

Keywords

Postextraction implant; Implant type 1; Socket-Shield; Soft Tissue volume; RCT

Outcome Measures

Primary Outcomes (1)

• Soft tissue volume

  Soft tissue volume changes after tooth extraction

  6 months

Secondary Outcomes (5)

• Surgery pain perception by Numerical Rating Scale

  Just after surgery

• Surgery satisfaction of the patient by Numerical Rating Scale

  Just after surgery

• General satisfaction of the patient by Numerical Rating Scale

  6 months after the beginning of treatment

• Esthetic satisfaction of the patient by Numerical Rating Scale

  3 months after after crown placement

• Function satisfaction of the patient by Numerical Rating Scale

  3 months after after crown placement

Study Arms (2)

Immediate Implant with SST (SST)

EXPERIMENTAL

Patients who will receive immediate implant placement using the Socket-Shield Technique.

Procedure: Dental implant placement after tooth extraction

Immediate Implant with biomaterial (GAP)

ACTIVE COMPARATOR

Patients who will receive immediate implant placement using bone biomaterials to fill the gap after complete extraction of the tooth.

Procedure: Dental implant placement after tooth extraction

Interventions

Dental implant placement after tooth extraction PROCEDURE

Immediate implant placement after partial or complete tooth extraction.

Also known as: Implant surgery

Immediate Implant with SST (SST); Immediate Implant with biomaterial (GAP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring single tooth extraction in lateral or anterior areas of the upper jaw.
• Teeth that do not present alteration or loss of the vestibular bone table.

You may not qualify if:

• Patients in whom surgical intervention is contraindicated.
• Teeth with alteration or loss of the vestibular bone table.
• Teeth with marginal recession \>2mm.
• Early or delayed failure of the implant placed with any of the three techniques.

Sponsors & Collaborators

• Aula Dental Avanzada: lead

Study Sites (1)

Clínica Dental Esteve

Alicante, Alicante, 03001, Spain

Location

Related Publications (14)

• Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

  PMID: 15691354 BACKGROUND

• Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.

  PMID: 24660198 BACKGROUND

• Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.

  PMID: 24894299 BACKGROUND

• Buser D, Chen ST, Weber HP, Belser UC. Early implant placement following single-tooth extraction in the esthetic zone: biologic rationale and surgical procedures. Int J Periodontics Restorative Dent. 2008 Oct;28(5):441-51.

  PMID: 18990995 BACKGROUND

• Seyssens L, De Lat L, Cosyn J. Immediate implant placement with or without connective tissue graft: A systematic review and meta-analysis. J Clin Periodontol. 2021 Feb;48(2):284-301. doi: 10.1111/jcpe.13397. Epub 2020 Nov 20.

  PMID: 33125754 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

• Mitsias ME, Siormpas KD, Kotsakis GA, Ganz SD, Mangano C, Iezzi G. The Root Membrane Technique: Human Histologic Evidence after Five Years of Function. Biomed Res Int. 2017;2017:7269467. doi: 10.1155/2017/7269467. Epub 2017 Nov 22.

  PMID: 29333449 BACKGROUND

• Baumer D, Zuhr O, Rebele S, Schneider D, Schupbach P, Hurzeler M. The socket-shield technique: first histological, clinical, and volumetrical observations after separation of the buccal tooth segment - a pilot study. Clin Implant Dent Relat Res. 2015 Feb;17(1):71-82. doi: 10.1111/cid.12076. Epub 2013 Apr 30.

  PMID: 23631704 BACKGROUND

• Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.

  PMID: 28333394 BACKGROUND

• Barbisan A, Dias CS, Bavia PF, Sapata VM, Cesar-Neto JB, Silva CO. Soft Tissues Changes After Immediate and Delayed Single Implant Placement in Esthetic Area: A Systematic Review. J Oral Implantol. 2015 Oct;41(5):612-9. doi: 10.1563/AAID-JOI-D-13-00095. Epub 2014 Jan 29.

  PMID: 24475930 BACKGROUND

• Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31.

  PMID: 27978602 BACKGROUND

• Huynh-Ba G, Hoders AB, Meister DJ, Prihoda TJ, Mills MP, Mealey BL, Cochran DL. Esthetic, clinical, and radiographic outcomes of two surgical approaches for single implant in the esthetic area: 1-year results of a randomized controlled trial with parallel design. Clin Oral Implants Res. 2019 Aug;30(8):745-759. doi: 10.1111/clr.13458. Epub 2019 Jun 7.

  PMID: 31099929 BACKGROUND

• Cosyn J, De Lat L, Seyssens L, Doornewaard R, Deschepper E, Vervaeke S. The effectiveness of immediate implant placement for single tooth replacement compared to delayed implant placement: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:224-241. doi: 10.1111/jcpe.13054.

  PMID: 30624808 BACKGROUND

• Bramanti E, Norcia A, Cicciu M, Matacena G, Cervino G, Troiano G, Zhurakivska K, Laino L. Postextraction Dental Implant in the Aesthetic Zone, Socket Shield Technique Versus Conventional Protocol. J Craniofac Surg. 2018 Jun;29(4):1037-1041. doi: 10.1097/SCS.0000000000004419.

  PMID: 29489581 BACKGROUND

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Guillem Esteve-Pardo

  Aula Dental Avanzada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 10 receiving immediate implant placement with Socket-Shield Technique and 10 receiving immediate implant placement with complete extraction of the tooth. (n=20)

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 17, 2021
• Study Start: March 1, 2021
• Primary Completion: December 25, 2025
• Study Completion: January 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)