ClinicalTrials.gg
CompletedNCT04803110Updated Nov 4, 2026

Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques

An interventional study of Dental implant placement after tooth extraction in Dental Implant, Tooth Extraction and Bone Resorption, sponsored by Aula Dental Avanzada. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Aula Dental Avanzada · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

After tooth extraction, the supporting tissues, bone and mucosa will undergo a loss of volume associated with the loss of the cementum-periodontal ligament-bone attachment complex.

This alteration in volume can affect aesthetic results, especially when the tooth involves the anterior area, where the alveolar bone is narrower.

To compensate for the lost volume loss, some authors promote delayed implant placement, which would facilitate soft tissue management after healing.

The conventional immediate implant placement technique proposes the use of bone regeneration biomaterials in the space between the implant wall and the residual vestibular bone. The aim of this technique is to compensate for this bone resorption, thus improving the aesthetic results. In the same sense of compensating for the resorption that will occur, some authors recommend the use of soft tissue grafts in the same operative act of extraction and placement of the immediate implant.

Some years ago, some authors presented the technique of partial extraction of the tooth as an alternative to the conventional technique of immediate implant placement after extraction with the aim of avoiding or minimising this resorption. The technique consists of leaving a piece of tooth (shield) inserted in the vestibular alveolar bone area so that the resorption process is slowed down.

The presence of bone between the dentine wall of the tooth fragment and the implant has been demonstrated in both animal and ex-vivo histological studies.

From a clinical point of view, the Socket-Shield or partial extraction technique has been shown to maintain the vestibular volume in post-extraction implants placed using this technique in both posterior and anterior areas with high aesthetic compromise, maintaining adequate clinical values and patient satisfaction.

On the other hand, a 2015 systematic review, comparing immediate and delayed implantation techniques, reports no significant differences between the two, especially at the soft tissue level, although it mentions a lack of quality in the RCTs analysed.

A 2017 randomized clinical trial compared the conventional immediate implant placement technique with the delayed or early implantation technique, advising against the former when aesthetics were compromised and limiting it to well-selected cases.

In contrast, another more recent randomized clinical trial found no aesthetic, clinical or radiographic differences between the two techniques, and reported similar levels of patient satisfaction.

Likewise, a higher rate of early failure has been found in the immediate implantation technique, mentioning the lack of randomised clinical studies comparing both techniques, especially in terms of soft tissue volume changes.

A recent randomised clinical study comparing the Socket-Shield technique with the conventional implant placement technique found better levels of marginal bone and pink aesthetic assessment in the former, considering it a safe and feasible technique in the anterior sector.

Given the lack of evidence in the literature, there is a palpable need for clinical studies to compare the best technique and/or timing of implant placement after tooth extraction.

02

Conditions studied

  • Dental Implant
  • Tooth Extraction
  • Bone Resorption

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Keywords

  • Postextraction implant
  • Implant type 1
  • Socket-Shield
  • Soft Tissue volume
  • RCT
03

In context

Bone Resorption

167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.

This study's enrollment of 20 is below the median of 24 across 146 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

Aula Dental Avanzada is the lead sponsor of 14 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients in whom surgical intervention is .
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Immediate Implant with SST (SST)

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

    Procedure: Dental implant placement after tooth extraction

  • Active comparator
    Immediate Implant with biomaterial (GAP)

    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

  • ProcedureDental implant placement after tooth extraction

    Immediate implant placement after partial or complete tooth extraction.

    Also known as: Implant surgery

06

What researchers measure

Primary outcomes

  1. Soft tissue volume

    Soft tissue volume changes after tooth extraction

    Time frame: 6 months

Secondary outcomes

  1. Surgery pain perception by Numerical Rating Scale

    Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain.

    Time frame: Just after surgery

  2. Surgery satisfaction of the patient by Numerical Rating Scale

    Patients satisfaction after surgery, being 0 not satisfied at all, and 10 very satisfied

    Time frame: Just after surgery

  3. General satisfaction of the patient by Numerical Rating Scale

    Patients general satisfaction 6 months after the beginning of treatment, being 0 not satisfied at all, and 10 very satisfied

    Time frame: 6 months after the beginning of treatment

  4. Esthetic satisfaction of the patient by Numerical Rating Scale

    Patients esthetic satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied

    Time frame: 3 months after after crown placement

  5. Function satisfaction of the patient by Numerical Rating Scale

    Patients function satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied

    Time frame: 3 months after after crown placement

07

Study locations

1 site
  • Clínica Dental Esteve
    Alicante, Alicante 03001, Spain
08

References and documents

Publications

  • 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. PubMed 15691354 ↗
  • 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. PubMed 24660198 ↗
  • 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. PubMed 24894299 ↗
  • 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. PubMed 18990995 ↗
  • 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. PubMed 20712701 ↗
  • 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. PubMed 30624808 ↗
  • 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. PubMed 33125754 ↗
  • 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. PubMed 29333449 ↗
  • 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. PubMed 23631704 ↗
  • 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. PubMed 28333394 ↗
  • 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. PubMed 24475930 ↗
  • 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. PubMed 27978602 ↗
  • 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. PubMed 31099929 ↗
  • 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. PubMed 29489581 ↗

Individual participant data

Plan to share: No — No plan to share with other researches.

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Active, not recruiting→Completed
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04803110
Lead sponsor
Aula Dental Avanzada
Responsible party
Guillem Esteve-Pardo (Principal Investigator, Aula Dental Avanzada) — Principal investigator
First posted
Mar 17, 2021
Start date
Mar 1, 2021
Primary completion
Dec 25, 2025
Completion
Jan 1, 2026
Last update
Nov 4, 2026

Study contacts

Guillem Esteve-Pardo
principal investigator · Aula Dental Avanzada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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