: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE

NCT02992366 | Unknown

• 1 other identifier: Cairoshi-con
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dental Implant Placement; Socket Shield Technique Implant Placement

Keywords

socket shield; volumetric tissue alteration; immediate implant

Outcome Measures

Primary Outcomes (1)

• Vertical and horizontal bone level

  9 months

Secondary Outcomes (2)

• Pocket probing depth

  9 months

• Labial Alveolar crestal bone height compared with the lingual side

  9 months

Study Arms (2)

socket shield (A)

EXPERIMENTAL

1. Following local anesthetic infiltration opposite to the root to be extracted the root is sectioned in a mesiodistal direction along its long axis as far apical as possible. 2. After sectioning the root into labial and palatal halves, the palatal half is removed with preservation of the labial root section. 3. The labial half is prepared to be Flushing or 1mm above the labial alveolar crest. Then thinned slightly to a concave contour in an apico-coronal and mesiodistal direction. 4. The implant will be inserted in place of the palatal half with the labial surface of the implant facing the labial root shield (root-implant interface) primary closure will not be attempted as the patients will undergo immediate non-functioning provisionization.

Procedure: implant placement

conventional immediate implant (B)

ACTIVE COMPARATOR

1. Following local anesthetic infiltration opposite to the root to be extracted non traumatic extraction of the tooth or remaining root by periotome. 2. The implant fixture will be inserted in the empty socket by conventional manner. primary closure will not be attempted as the patients will undergo immediate non-functioning provisionization.

Procedure: implant placement

Interventions

implant placement PROCEDURE

implant placement

conventional immediate implant (B); socket shield (A)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with remaining roots in the esthetic zone with intact periodontal condition indicated for extraction.
• Physically able to tolerate conventional surgical and restorative procedures
• Signing of an informed consent form
• Implant insertion torque \> 32 N cm with good primary stability

You may not qualify if:

• Systemic diseases contraindicating implant placement eg uncontrolled diabetes
• Severe bruxism
• Active infection in the teeth to be treated
• Vertical root fractures with displacement in the teeth of the surgical area

Sponsors & Collaborators

• Cairo University: lead

Related Publications (26)

• Cardaropoli G, Araujo 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. doi: 10.1034/j.1600-051x.2003.00366.x.

  PMID: 12956657 BACKGROUND

• Araujo MG, Sukekava F, Wennstrom 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. doi: 10.1111/j.1600-051X.2005.00726.x.

  PMID: 15882225 BACKGROUND

• 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.

  PMID: 12956475 BACKGROUND

• 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.

  PMID: 15635945 BACKGROUND

• 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. doi: 10.1111/j.1600-0501.2006.01270.x.

  PMID: 16907764 BACKGROUND

• 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.

  PMID: 18983313 BACKGROUND

• 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. doi: 10.14219/jada.archive.1960.0152. No abstract available.

  PMID: 13793201 BACKGROUND

• Fickl S, Zuhr O, Wachtel H, Stappert CF, Stein JM, Hurzeler 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. Epub 2008 Aug 17.

  PMID: 18713258 BACKGROUND

• Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.

  PMID: 5224784 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

• 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. doi: 10.1111/j.1600-051X.2004.00565.x.

  PMID: 15367183 BACKGROUND

• Hammerle CH, Araujo 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.

  PMID: 22211307 BACKGROUND

• Chen ST, Wilson TG Jr, Hammerle 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.

  PMID: 15635942 BACKGROUND

• Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hurzeler 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.

  PMID: 19419446 BACKGROUND

• Vermylen K, Collaert B, Linden U, Bjorn AL, De Bruyn H. Patient satisfaction and quality of single-tooth restorations. Clin Oral Implants Res. 2003 Feb;14(1):119-24. doi: 10.1034/j.1600-0501.2003.140116.x.

  PMID: 12562374 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

• 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.

  PMID: 24392492 BACKGROUND

• 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. doi: 10.11607/prd.1346.

  PMID: 23342355 BACKGROUND

• Scheuber S, Bosshardt D, Bragger 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.

  PMID: 23720038 BACKGROUND

• Parlar A, Bosshardt DD, Unsal B, Cetiner D, Haytac 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. doi: 10.1111/j.1600-0501.2005.01123.x.

  PMID: 15877745 BACKGROUND

• 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.

  PMID: 19604282 BACKGROUND

• 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.

  PMID: 18724850 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

• 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. doi: 10.1902/jop.1989.60.12.683.

  PMID: 2614633 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

• 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

Study Officials

• Mohamed Galal G. Beheiri, professor

  senior supervisor

  STUDY DIRECTOR

Central Study Contacts

Ahmed G. Khater, Bsc

CONTACT

+201111717300; drahmedgamalkhater@gmail.com

Mostafa I. Shindy, lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial surgery resident in ministry of health

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 14, 2016

Record last verified: 2016-12