Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques

Dental Implant Clinical Trial

Official title:

Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques: Randomized Comparative Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803110
• Other study ID #: POSTEXO
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Aula Dental Avanzada
• Contact: Guillem Esteve-Pardo, DDS
• Phone: +34 654089109
• Email: guillemjoes[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 30 patients, they will be divided into groups of 10 and will be randomized using the random.org program. The volume of the soft tissues will be recorded by means of a hydrocolloid impression before tooth extraction and 6 months later. The soft tissue dimensional changes produced will be digitally evaluated and statistically analyzed.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Bone Resorption
• Dental Implant
• Tooth Extraction

Intervention

Procedure:
• Dental implant placement after tooth extraction
Immediate implant placement after partial or complete tooth extraction.

Locations

Country	Name	City	State
Spain	Clínica Dental Esteve	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. E — View Citation

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. — View Citation

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; — View Citation

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/S — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue volume	Soft tissue volume changes after tooth extraction	6 months
Secondary	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.	Just after surgery
Secondary	Surgery satisfaction of the patient by Numerical Rating Scale	Patients satisfaction after surgery, being 0 not satisfied at all, and 10 very satisfied	Just after surgery
Secondary	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	6 months after the beginning of treatment
Secondary	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	3 months after after crown placement
Secondary	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	3 months after after crown placement