Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage

Bacterial Infections Clinical Trial

Official title:

Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328051
• Other study ID #: UBarcelonaOralSurgery2
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: December 13, 2021

Study information

• Verified date: March 2020
• Source: University of Barcelona
• Contact: Laura Rubianes-Porta, DDS, MS
• Phone: +34630873804
• Email: od074964[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.

Description:

Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.

Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.

Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 13, 2021
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who accept signing voluntarily the informed consent before doing any action related to the study.

• =18-years-old patients.

• Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.

• Single implants successfully osseointegrated placed at least 16 weeks post-extraction.

• O'Leary plaque index and or bleeding on probing =25%.

• Dental implants with screwed-retained prosthesis.

Exclusion Criteria:

• Systemic diseases that can interfere dental implant placement.

• Any contraindication for surgery procedures.

• Heavy smokers (> 20cig/day).

• Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.

• Patients who have had participated with another clinical trial the last 30 days.

• Pregnant women or in lactation.

• Patients with bad oral hygiene or not motivated.

• Probing pockets depths with bleeding of =4 mm on a tooth adjacent to the edentulous space.

• Guided bone regeneration required in the same time of the implant placement.

Related Conditions & MeSH terms

• Bacterial Infections
• Bone Diseases, Metabolic
• Bone Loss
• Dental Implant

Intervention

Other:
• Dental Implant Placement
Antibiotic prophylaxis will be done. After rinsing with 0.12 % chlorhexidine, patients will receive local anaesthesia. A crestal incision will be done and a mucoperiostic flap will be raised. As the commercial specifies, progressive diameter drills will be used under constant sterile saline irrigation to prepare the implant site. Once finished the drilling sequence, one investigator will open the opaque envelope to know which type of implant, depending on the connection, has to be placed by the surgeon. Dental implant will be placed crestally and depending if it has primary stability or not, it will be leaded submerged or non-submerged. The flap will be repositioned and sutured without tension with 4/0 polyamide. Postoperative instructions and medication will be prescribed and explained.

Locations

Country	Name	City	State
Spain	University of Barcelona	L'Hospitalet De Llobregat	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (15)

Abrahamsson I, Berglundh T. Effects of different implant surfaces and designs on marginal bone-level alterations: a review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:207-15. doi: 10.1111/j.1600-0501.2009.01783.x. Review. — View Citation

Albrektsson T, Donos N; Working Group 1. Implant survival and complications. The Third EAO consensus conference 2012. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:63-5. doi: 10.1111/j.1600-0501.2012.02557.x. Review. — View Citation

Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. Review. — View Citation

Astrand P, Engquist B, Dahlgren S, Gröndahl K, Engquist E, Feldmann H. Astra Tech and Brånemark system implants: a 5-year prospective study of marginal bone reactions. Clin Oral Implants Res. 2004 Aug;15(4):413-20. — View Citation

Brånemark PI, Adell R, Breine U, Hansson BO, Lindström J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. — View Citation

Buser D, Ingimarsson S, Dula K, Lussi A, Hirt HP, Belser UC. Long-term stability of osseointegrated implants in augmented bone: a 5-year prospective study in partially edentulous patients. Int J Periodontics Restorative Dent. 2002 Apr;22(2):109-17. — View Citation

Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334. Review. — View Citation

Isidor F. Influence of forces on peri-implant bone. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:8-18. Review. — View Citation

Koo KT, Lee EJ, Kim JY, Seol YJ, Han JS, Kim TI, Lee YM, Ku Y, Wikesjö UM, Rhyu IC. The effect of internal versus external abutment connection modes on crestal bone changes around dental implants: a radiographic analysis. J Periodontol. 2012 Sep;83(9):1104-9. doi: 10.1902/jop.2011.110456. Epub 2011 Dec 6. — View Citation

Lin MI, Shen YW, Huang HL, Hsu JT, Fuh LJ. A retrospective study of implant-abutment connections on crestal bone level. J Dent Res. 2013 Dec;92(12 Suppl):202S-7S. doi: 10.1177/0022034513510322. Epub 2013 Oct 24. — View Citation

Malevez C, Hermans M, Daelemans P. Marginal bone levels at Brånemark system implants used for single tooth restoration. The influence of implant design and anatomical region. Clin Oral Implants Res. 1996 Jun;7(2):162-9. — View Citation

Nishioka RS, de Vasconcellos LG, de Melo Nishioka GN. Comparative strain gauge analysis of external and internal hexagon, Morse taper, and influence of straight and offset implant configuration. Implant Dent. 2011 Apr;20(2):e24-32. doi: 10.1097/ID.0b013e318211fce8. — View Citation

Oh TJ, Yoon J, Misch CE, Wang HL. The causes of early implant bone loss: myth or science? J Periodontol. 2002 Mar;73(3):322-33. Review. — View Citation

Quirynen M, Naert I, van Steenberghe D. Fixture design and overload influence marginal bone loss and fixture success in the Brånemark system. Clin Oral Implants Res. 1992 Sep;3(3):104-11. — View Citation

Vidyasagar L, Apse P. Dental implant design and biological effects on bone implant interface. Baltic Dent Maxillofac J. 2004;6:51-4.

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vertical Marginal Bone Loss (VMBL)	Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.	Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Secondary	Vertical Marginal Bone Loss Tax	Vertical bone loss in millimetres per implant and unit of time.	12 months after prosthesis placement.
Secondary	Early implant failure	Implant with mobility or failure of the osseointegration process before the prosthesis placement.	Since implant placement (Timing 0) through prosthesis placement (Timing 1).
Secondary	Late implant failure	Implant with mobility or failure of the osseointegration process after the prosthesis placement.	Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Secondary	Probing pocket depth	Distance in millimetres from the gingival margin to the bottom of the periodontal pocket measured with the periodontal probe. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).	Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Secondary	Mucosal recession	Distance in millimetres from the cemento-enamel junction of the tooth or from the implant platform to the gingival margin when it is located apically. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).	Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Secondary	Mucosal hyperplasia	Distance in millimetres from the gingival margin to the cemento-enamel junction of the tooth or to the implant platform when the gingiva is located more coronal than them. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).	Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Secondary	Clinical attachment level	Probing pocket depth (mm) plus the recession (mm) or probing pocket depth minus the hyperplasia (mm). Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal).	Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Secondary	O'Leary plaque index	Plaque presence in the dentogingival or implantogingival union. Determined in four points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual). Expressed as the percentage (%) of tooth or implant surfaces with plaque presence divided with the total of tooth or implant surfaces in mouth and multiplied per 100.	First visit
Secondary	Bleeding on probing	Presence of blood in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with blood divided with the total of tooth or implant surfaces in mouth and multiplied per 100.	Since first visit through study completion (Timing 5), an average of 1 year.
Secondary	Suppuration on probing	Presence of purulent material in the gingival margin after determining the probing pocket depth. Determined in six points per tooth or implant (Buccal: mesial, medial and distal. Palatal or lingual: mesial, medial and distal). Expressed as the percentage (%) of tooth or implant surfaces with pus divided with the total of tooth or implant surfaces in mouth and multiplied per 100.	Since first visit through study completion (Timing 5), an average of 1 year.
Secondary	Prosthetic complications	Screw (which connects the crown with the implant) fracture or prosthesis fracture, chipping of the ceramic prosthesis, loosening of the screw (which connects the crown with the implant) or any other prosthetic components.	Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
Secondary	Bacterial leakage	Quantitative PCR in real time to determine the total amount of bacteria and in particular, of 10 pathogenic species: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia, Peptostreptococcus micros, Fusobacterium nucleatum, Campylobacter rectus, Eikenella corrodens and Candida albicans.	12 months after prosthesis placement.