Comparing the Secondary Stability of Dental Implants: Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla

NCT ID: NCT02309125

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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These two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient.

A 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time.

Immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm

early loaded side: implants will be submerged from the surgery time till loading time (2 month).

Conditions

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Dental Implant Transmucosal Healing Bone Loss

Keywords

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immediate gradual loading

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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implant A

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

Group Type EXPERIMENTAL

immediate progressive loading using gingival formers

Intervention Type PROCEDURE

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 B

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

Group Type OTHER

submerged healing

Intervention Type PROCEDURE

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

Interventions

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immediate progressive loading using gingival formers

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).

Intervention Type PROCEDURE

submerged healing

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Systemic disease.
2. Irradiated bone (radiotherapy).
3. Heavy smoking habit.
4. Patients undergoing long-term immunosuppressive therapy.
5. Atrophic ridges.
6. Presence of any local bony lesion.
7. Presence of mandibular parafunctional habits
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Elhassan Mohamed Elsayed Mostafa Mossad

Master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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elhassan mossad, oral surgeon

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of oral & Dental Medicine. Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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elhassan mossad, oral surgeon

Role: CONTACT

Phone: +201111113770

Email: [email protected]

Facility Contacts

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Elhassan Mossad, oral surgeon

Role: primary

Mohamed kashaba, lecturer (PHD)

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 15777325 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 23724215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9638008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9579618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9249642 (View on PubMed)

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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.

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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

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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.

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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.

Reference Type BACKGROUND
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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.

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Other Identifiers

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immediate_early_loading

Identifier Type: -

Identifier Source: org_study_id