NCT02309125

Brief Summary

The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol. Research Hypothesis Immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 5, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

December 3, 2014

Last Update Submit

December 4, 2014

Conditions

Dental ImplantTransmucosal HealingBone Loss

Keywords

immediate gradual loading

Outcome Measures

Primary Outcomes (1)

  • secondary stability of dental implant (ISQ Osstell Mentol)

    ISQ Osstell Mentol

    2 month

Secondary Outcomes (1)

  • Bone loss using Periapical Radiographic (Long Cone Paralleling technique)

    2 month

Study Arms (2)

implant A

EXPERIMENTAL

will include implants with immediate progressive loading using gingival formers of different sizes

Procedure: immediate progressive loading using gingival formers

implant B

OTHER

The implants will remain submerged from surgery time till loading time 2 month.(submerged healing)

Procedure: submerged healing

Interventions

immediate progressive loading using gingival formersPROCEDURE

Implant placement will be 1 mm subcrestally, and it will receive transmucosal healing using gingival former. The gingival former will be replaced every 2 weeks by consequent larger size gingival former (at surgery time group A will receive 2 mm height gingival former which will be swapped by,3 mm, 4 mm and the last is 5 mm).

implant A
submerged healingPROCEDURE

the implant placement will be 1 mm subcrestally, and it will receive unloaded healing.(submerged healing)

implant B

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with bilateral Partial or complete edentulous areas in maxillary premolar/molar region.
  • Free medical history.
  • Enough bone quantity.
  • Enough keratinized mucosa

You may not qualify if:

  • Systemic disease.
  • Irradiated bone (radiotherapy).
  • Heavy smoking habit.
  • Patients undergoing long-term immunosuppressive therapy.
  • Atrophic ridges.
  • Presence of any local bony lesion.
  • Presence of mandibular parafunctional habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of oral & Dental Medicine. Cairo University

Cairo, Egypt

RECRUITING

Related Publications (21)

  • Appleton RS, Nummikoski PV, Pigno MA, Cronin RJ, Chung KH. A radiographic assessment of progressive loading on bone around single osseointegrated implants in the posterior maxilla. Clin Oral Implants Res. 2005 Apr;16(2):161-7. doi: 10.1111/j.1600-0501.2004.01089.x.

    PMID: 15777325BACKGROUND

  • Attard NJ, Zarb GA. Immediate and early implant loading protocols: a literature review of clinical studies. J Prosthet Dent. 2005 Sep;94(3):242-58. doi: 10.1016/j.prosdent.2005.04.015.

    PMID: 16126077BACKGROUND

  • Berglundh T, Abrahamsson I, Lindhe J. Bone reactions to longstanding functional load at implants: an experimental study in dogs. J Clin Periodontol. 2005 Sep;32(9):925-32. doi: 10.1111/j.1600-051X.2005.00747.x.

    PMID: 16104954BACKGROUND

  • Buchter A, Wiechmann D, Koerdt S, Wiesmann HP, Piffko J, Meyer U. Load-related implant reaction of mini-implants used for orthodontic anchorage. Clin Oral Implants Res. 2005 Aug;16(4):473-9. doi: 10.1111/j.1600-0501.2005.01149.x.

    PMID: 16117773BACKGROUND

  • Duyck J, Vandamme K, Geris L, Van Oosterwyck H, De Cooman M, Vandersloten J, Puers R, Naert I. The influence of micro-motion on the tissue differentiation around immediately loaded cylindrical turned titanium implants. Arch Oral Biol. 2006 Jan;51(1):1-9. doi: 10.1016/j.archoralbio.2005.04.003. Epub 2005 May 31.

    PMID: 15922992BACKGROUND

  • Duyck J, Vrielinck L, Lambrichts I, Abe Y, Schepers S, Politis C, Naert I. Biologic response of immediately versus delayed loaded implants supporting ill-fitting prostheses: an animal study. Clin Implant Dent Relat Res. 2005;7(3):150-8. doi: 10.1111/j.1708-8208.2005.tb00059.x.

    PMID: 16219245BACKGROUND

  • Ghoveizi R, Alikhasi M, Siadat MR, Siadat H, Sorouri M. A radiographic comparison of progressive and conventional loading on crestal bone loss and density in single dental implants: a randomized controlled trial study. J Dent (Tehran). 2013 Mar;10(2):155-63. Epub 2013 Mar 31.

    PMID: 23724215BACKGROUND

  • Isidor F. Mobility assessment with the Periotest system in relation to histologic findings of oral implants. Int J Oral Maxillofac Implants. 1998 May-Jun;13(3):377-83.

    PMID: 9638008BACKGROUND

  • Piattelli A, Corigliano M, Scarano A, Costigliola G, Paolantonio M. Immediate loading of titanium plasma-sprayed implants: an histologic analysis in monkeys. J Periodontol. 1998 Mar;69(3):321-7. doi: 10.1902/jop.1998.69.3.321.

    PMID: 9579618BACKGROUND

  • Piattelli A, Scarano A, Piattelli M, Bertolai R, Panzoni E. Histologic aspects of the bone and soft tissues surrounding three titanium non-submerged plasma-sprayed implants retrieved at autopsy: a case report. J Periodontol. 1997 Jul;68(7):694-700. doi: 10.1902/jop.1997.68.7.694.

    PMID: 9249642BACKGROUND

  • Soballe K, Hansen ES, Brockstedt-Rasmussen H, Hjortdal VE, Juhl GI, Pedersen CM, Hvid I, Bunger C. Gap healing enhanced by hydroxyapatite coating in dogs. Clin Orthop Relat Res. 1991 Nov;(272):300-7.

    PMID: 1657476BACKGROUND

  • Szmukler-Moncler S, Piattelli A, Favero GA, Dubruille JH. Considerations preliminary to the application of early and immediate loading protocols in dental implantology. Clin Oral Implants Res. 2000 Feb;11(1):12-25. doi: 10.1034/j.1600-0501.2000.011001012.x.

    PMID: 11168189BACKGROUND

  • Frost HM. Perspectives: bone's mechanical usage windows. Bone Miner. 1992 Dec;19(3):257-71. doi: 10.1016/0169-6009(92)90875-e.

    PMID: 1472896BACKGROUND

  • Frost HM. A 2003 update of bone physiology and Wolff's Law for clinicians. Angle Orthod. 2004 Feb;74(1):3-15. doi: 10.1043/0003-3219(2004)0742.0.CO;2.

    PMID: 15038485BACKGROUND

  • Misch CE, Hoar J, Beck G, Hazen R, Misch CM. A bone quality-based implant system: a preliminary report of stage I & stage II. Implant Dent. 1998;7(1):35-42. doi: 10.1097/00008505-199804000-00004.

    PMID: 9588972BACKGROUND

  • Jones HH, Priest JD, Hayes WC, Tichenor CC, Nagel DA. Humeral hypertrophy in response to exercise. J Bone Joint Surg Am. 1977 Mar;59(2):204-8.

    PMID: 845205BACKGROUND

  • Martin B. Aging and strength of bone as a structural material. Calcif Tissue Int. 1993;53 Suppl 1:S34-9; discussion S39-40. doi: 10.1007/BF01673400.

    PMID: 8275378BACKGROUND

  • Quinlan P, Nummikoski P, Schenk R, Cagna D, Mellonig J, Higginbottom F, Lang K, Buser D, Cochran D. Immediate and early loading of SLA ITI single-tooth implants: an in vivo study. Int J Oral Maxillofac Implants. 2005 May-Jun;20(3):360-70.

    PMID: 15973947BACKGROUND

  • Roberts WE, Turley PK, Brezniak N, Fielder PJ. Implants: Bone physiology and metabolism. CDA J. 1987 Oct;15(10):54-61. No abstract available.

    PMID: 3331974BACKGROUND

  • Degidi M, Iezzi G, Scarano A, Piattelli A. Immediately loaded titanium implant with a tissue-stabilizing/maintaining design ('beyond platform switch') retrieved from man after 4 weeks: a histological and histomorphometrical evaluation. A case report. Clin Oral Implants Res. 2008 Mar;19(3):276-82. doi: 10.1111/j.1600-0501.2007.01449.x. Epub 2007 Dec 13.

    PMID: 18081870BACKGROUND

  • Diab T, Sit S, Kim D, Rho J, Vashishth D. Age-dependent fatigue behaviour of human cortical bone. Eur J Morphol. 2005 Feb-Apr;42(1-2):53-9. doi: 10.1080/09243860500095539.

    PMID: 16123024BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • elhassan mossad, oral surgeon

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

elhassan mossad, oral surgeon

CONTACT

+201111113770mossadelhassan@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

December 5, 2014

Record last verified: 2014-11

Locations

EG(1)