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Dental Implant PlacementNCT02992366

: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE

A study testing implant placement in people with Dental Implant Placement and Socket Shield Technique Implant Placement, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
implant placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Dec 2016to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Ahmed G. Khater, Bsc contact

+201111717300

drahmedgamalkhater@gmail.com

Mostafa I. Shindy, lecturer contact

About this study

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

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

Read the detailed 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

Being tested
implant placement
Keywords
socket shield, volumetric tissue alteration, immediate implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implant placementProcedure or surgery

    implant placement

Study groups in NCT02992366
Study groupRoleWhat they receive
socket shield (A)Experimental1. 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.
Receives: Procedure: implant placement
conventional immediate implant (B)Active comparator1. 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.
Receives: Procedure: implant placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vertical and horizontal bone level

    Measured: 9 months

Secondary outcomes (2)

  1. Pocket probing depth

    Measured: 9 months

  2. Labial Alveolar crestal bone height compared with the lingual side

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02992366
Sponsor's protocol ID
Cairoshi-con
Status last verified
Dec 2016
First submitted
10 Dec 2016
Last updated
14 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 12956657

  • 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.

    PubMed 15882225

  • 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.

    PubMed 12956475

  • 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.

    PubMed 15635945

  • 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.

    PubMed 16907764

  • 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.

    PubMed 18983313

  • 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.

    PubMed 13793201

  • 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.

    PubMed 18713258

  • 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.

    PubMed 5224784

  • 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.

    PubMed 22211305

  • 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.

    PubMed 15367183

  • 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.

    PubMed 22211307

  • 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.

    PubMed 15635942

  • 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.

    PubMed 19419446

  • 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.

    PubMed 12562374

Questions about this trial

What is this clinical trial studying?

A study testing implant placement in people with Dental Implant Placement and Socket Shield Technique Implant Placement, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed G. Khater, Bsc (+201111717300, drahmedgamalkhater@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertical and horizontal bone level (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02992366, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.

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