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

Bone Loss Clinical Trial

Official title:

Split Mouth Clinical Study to Compare the Secondary Stability of Dental Implants Using Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02309125
• Other study ID #: immediate_early_loading
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2014
• Last updated: December 4, 2014
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2014
• Source: Cairo University
• Contact: elhassan mossad, oral surgeon
• Phone: +201111113770
• Email: mossadelhassan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Cairo University Research Ethics Committee (REC) Egypt':'
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bone Loss
• Dental Implant
• Transmucosal Healing

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of oral & Dental Medicine. Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Büchter 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. — View Citation

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. Epub 2007 Dec 13. — View Citation

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. — View Citation

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. Epub 2005 May 31. — View Citation

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. — View Citation

Frost HM. A 2003 update of bone physiology and Wolff's Law for clinicians. Angle Orthod. 2004 Feb;74(1):3-15. Review. — View Citation

Frost HM. Perspectives: bone's mechanical usage windows. Bone Miner. 1992 Dec;19(3):257-71. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Martin B. Aging and strength of bone as a structural material. Calcif Tissue Int. 1993;53 Suppl 1:S34-9; discussion S39-40. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Roberts WE, Turley PK, Brezniak N, Fielder PJ. Implants: Bone physiology and metabolism. CDA J. 1987 Oct;15(10):54-61. Review. — View Citation

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

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. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	secondary stability of dental implant (ISQ Osstell Mentol)	ISQ Osstell Mentol	2 month	No
Secondary	Bone loss using Periapical Radiographic (Long Cone Paralleling technique)	using Periapical Radiographic (Long Cone Paralleling technique)	2 month	No