: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE

Dental Implant Placement Clinical Trial

Official title:

IMMEDIATE IMPLANT PLACEMENT IN THE ESTHETIC ZONE: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE FOR PRESERVATION OF LABIAL ALVEOLAR BONE INTEGRITY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02992366
• Other study ID #: Cairoshi-con
• Status: Not yet recruiting
• Phase: N/A
• First received: December 10, 2016
• Last updated: December 10, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: Ahmed G. Khater, Bsc
• Phone: +201111717300
• Email: drahmedgamalkhater[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.

Description:

To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.

PICO

• P: patient require immediate dental implant placement for esthetic consideration

• I: socket shield technique

• C: conventional immediate implant placement

• O:

Outcome name Measuring device Measuring unit Primary outcome Vertical and horizontal bone level Cone beam Computer Tomography (CBCT) Millimeter Secondary outcome (a) Pocket probing depth Periodontal probe Millimeter Secondary outcome (b) Labial Alveolar crestal bone height compared with the lingual side Cone beam Computer Tomography (CBCT) Millimeter

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with remaining roots in the esthetic zone with intact periodontal condition indicated for extraction.

2. Physically able to tolerate conventional surgical and restorative procedures

3. Signing of an informed consent form

4. Implant insertion torque > 32 N cm with good primary stability

Exclusion Criteria:

1. Systemic diseases contraindicating implant placement eg uncontrolled diabetes

2. Severe bruxism

3. Active infection in the teeth to be treated

4. Vertical root fractures with displacement in the teeth of the surgical area

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Implant Placement
• Socket Shield Technique Implant Placement

Intervention

Procedure:
• implant placement
implant placement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (26)

AMLER MH, JOHNSON PL, SALMAN I. Histological and histochemical investigation of human alveolar socket healing in undisturbed extraction wounds. J Am Dent Assoc. 1960 Jul;61:32-44. — View Citation

Araújo MG, Sukekava F, Wennström JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. — View Citation

Bäumer D, Zuhr O, Rebele S, Schneider D, Schupbach P, Hürzeler 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. — View Citation

Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. — View Citation

Botticelli D, Persson LG, Lindhe J, Berglundh T. Bone tissue formation adjacent to implants placed in fresh extraction sockets: an experimental study in dogs. Clin Oral Implants Res. 2006 Aug;17(4):351-8. — View Citation

Bowers GM, Chadroff B, Carnevale R, Mellonig J, Corio R, Emerson J, Stevens M, Romberg E. Histologic evaluation of new attachment apparatus formation in humans. Part III. J Periodontol. 1989 Dec;60(12):683-93. — View Citation

Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61. Review. — View Citation

Cardaropoli G, Araújo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. — 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. Review. — View Citation

Chen ST, Wilson TG Jr, Hämmerle CH. Immediate or early placement of implants following tooth extraction: review of biologic basis, clinical procedures, and outcomes. Int J Oral Maxillofac Implants. 2004;19 Suppl:12-25. Review. — View Citation

Cherel F, Etienne D. Papilla preservation between two implants: a modified socket-shield technique to maintain the scalloped anatomy? A case report. Quintessence Int. 2014 Jan;45(1):23-30. doi: 10.3290/j.qi.a30765. — View Citation

Davarpanah M, Szmukler-Moncler S. Unconventional implant treatment: I. Implant placement in contact with ankylosed root fragments. A series of five case reports. Clin Oral Implants Res. 2009 Aug;20(8):851-6. doi: 10.1111/j.1600-0501.2008.01653.x. — View Citation

Donos N, Mardas N, Chadha V. Clinical outcomes of implants following lateral bone augmentation: systematic assessment of available options (barrier membranes, bone grafts, split osteotomy). J Clin Periodontol. 2008 Sep;35(8 Suppl):173-202. doi: 10.1111/j.1600-051X.2008.01269.x. Review. — View Citation

Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hürzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x. — View Citation

Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler MB. Hard tissue alterations after socket preservation: an experimental study in the beagle dog. Clin Oral Implants Res. 2008 Nov;19(11):1111-8. doi: 10.1111/j.1600-0501.2008.01575.x. — View Citation

Fickl S, Zuhr O, Wachtel H, Stappert CF, Stein JM, Hürzeler MB. Dimensional changes of the alveolar ridge contour after different socket preservation techniques. J Clin Periodontol. 2008 Oct;35(10):906-13. doi: 10.1111/j.1600-051X.2008.01305.x. — View Citation

Hämmerle CH, Araújo MG, Simion M; Osteology Consensus Group 2011.. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x. Review. Erratum in: Clin Oral Implants Res. 2012 May;23(5):641. — View Citation

Hürzeler 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

Kan JY, Rungcharassaeng K. Proximal socket shield for interimplant papilla preservation in the esthetic zone. Int J Periodontics Restorative Dent. 2013 Jan-Feb;33(1):e24-31. — View Citation

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. Review. — View Citation

Parlar A, Bosshardt DD, Unsal B, Cetiner D, Haytaç C, Lang NP. New formation of periodontal tissues around titanium implants in a novel dentin chamber model. Clin Oral Implants Res. 2005 Jun;16(3):259-67. — View Citation

Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. — View Citation

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. — View Citation

Scheuber S, Bosshardt D, Brägger U, von Arx T. [Implant therapy following trauma of the anterior teeth – a new method for alveolar ridge preservation after post-traumatic ankylosis and external root resorption]. Schweiz Monatsschr Zahnmed. 2013;123(5):417-39. French, German. — View Citation

Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23. — View Citation

Vermylen K, Collaert B, Lindén U, Björn AL, De Bruyn H. Patient satisfaction and quality of single-tooth restorations. Clin Oral Implants Res. 2003 Feb;14(1):119-24. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical and horizontal bone level		9 months	No
Secondary	Pocket probing depth		9 months	No
Secondary	Labial Alveolar crestal bone height compared with the lingual side		9 months	No