Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.

Alveolar Bone Loss Clinical Trial

Official title:

Impact of Implant Abutment Dis-/Reconnection on Peri-Implant Marginal Bone Loss - Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617212
• Other study ID #: 1.310.562
• Status: Completed
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2024
• Source: Fortaleza University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.

Description:

The proposed study is a randomized clinical trial in which the participants will be allocated into one of the two arms according to the proposed intervention: experimental group, in which the abutments will be permanently connected immediately at the implant placement procedure; and control group (active comparator) with conventional treatment, where the abutments will be disconnected and reconnected three times.

Considering the inclusion and exclusion criteria related to oral and systemic health, a sample of participants will be selected among those partially edentulous patients who seek for dental implants treatment at the Fortaleza University School of Dentistry.

The sample size has been calculated based on the standard deviation of 0.17 mm, significance level of 5% and 80% statistical test power. To detect a clinically significant difference of 0.2 mm, each group should be composed of 11 participants. Therefore, considering a 10% margin for possible dropouts or missing data, the study will include 24 participants divided into two groups. Each participant will receive one or two implants according to his/her needs, so the study may include more than 24 implants.

A single surgeon will perform the implant surgical procedure in order to reduce variations inherent to clinical experience. After local anesthesia and incision on the top of the alveolar ridge, the bone will be exposed by the mucoperiosteal flap elevation. The mucosal thickness will be measured at implant sites, before the lingual/palatal flap elevation, with a periodontal probe.

The drilling sequence will be done according to manufacturer's recommendations, under saline solution irrigation, intermittent movements and speed up to 1200rpm.

The implants should develop a final insertion torque of 32Ncm or above to enable abutment connection torque, indicated at the experimental arm. The implant primary stability will be also measured by resonance frequency analysis (Osstell; Osstell AB, Gothenburg, Sweden). A minimum 65 ISQ will be required to a single-stage surgery. Thus, those implants that do not contemplate these requirements will be excluded from the study and will receive a conventional treatment with two-stage surgery if necessary.

Before finishing the surgical procedure, the volunteers will be randomly assigned to one of the two arms by opening sealed envelopes with a random sequence generated by Excel (Microsoft, Redmond, Washington, USA). Therefore, the surgeon will identify each volunteer's arm only after the end of drilling, insertion and stabilization of the implants.

Each implant allocated at the control arm (active comparator) will receive conventional treatment with three abutment disconnections and reconnections. At the experimental arm, each implant will receive the prosthetic abutment in a definitive way immediately at the surgical procedure, avoiding any abutment disconnection.

The surgeries of both arms will be finished with suture, drug prescription and postoperative recommendations. All implants will receive temporary crowns at three months and definitive prosthesis until six months after surgery.

Intraoral radiographs will be done with paralleling technique immediately after surgery (baseline) and at 3, 6, 12 and 24 months later. The radiographs will have its dimensions corrected at the ImageJ software (National Institutes of Health, Bethesda, Maryland, USA) having implant known dimensions as reference.

Each implant will have its radiographs evaluated by a previously calibrated examiner with a minimum of 0.8 intra-rater reliability for the intraclass correlation coefficient. The examiner will not know to which arm the X-rays belong.

Primary and secondary outcomes data will be submitted to normality test and compared using statistical tests for paired and unpaired samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Partially edentulous patients requiring dental implant treatment for one or two dental units;

• Occlusal stability and regular occlusal plane;

• Enough space for implant and prosthesis;

• Good periodontal health

• Keratinized mucosa width > 4mm;

• Implant primary stability > 65 ISQ and insertion torque > 20Ncm;

Exclusion Criteria:

• Diabetes mellitus;

• Treatment with bisphosphonates;

• Head and neck irradiation;

• General contraindications to oral surgery;

• Pregnancy;

• Bone graft;

• Bruxism;

• Smoking habits.

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Procedure:
• Implant surgery
The volunteers will receive one or two dental implant(s) placed by a surgical procedure, under local anesthesia and careful soft and hard tissue handling. After implant insertion, the volunteers will be randomly assigned to one arm.

Device:
• Three abutment dis-/reconnections.
At the active comparator arm, each implant will receive a titanium healing abutment during the surgery, according to manufacturer's recommendations. Three dis-/reconnections of abutments will be performed after the soft tissue healing period: the first, after 8 weeks, for adjustment of the emergence profile by healing abutment changing; the second, 10 weeks after surgery, for intra-oral prosthetic abutment selection; and the third, 12 weeks after surgery, for the prosthetic abutment definitive connection with the manufacturer recommended torque.
• No abutment dis-/reconnections.
Each experimental arm implant will receive its definitive prosthetic abutment at the surgical procedure. The manufacturer recommended torque will be applied so that no disconnection of the abutment will occur during and after completion of the treatment. The abutment will receive healing caps, which shall remain in position until the end of 12 weeks after surgery.

Locations

Country	Name	City	State
Brazil	Fortaleza University; Health Sciences Center; School of Dentistry.	Fortaleza	Ceará

Sponsors (2)

Lead Sponsor	Collaborator
Fortaleza University	Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

Abrahamsson I, Berglundh T, Lindhe J. The mucosal barrier following abutment dis/reconnection. An experimental study in dogs. J Clin Periodontol. 1997 Aug;24(8):568-72. doi: 10.1111/j.1600-051x.1997.tb00230.x. — View Citation

Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4. — 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. No abstract available. — View Citation

Becker K, Mihatovic I, Golubovic V, Schwarz F. Impact of abutment material and dis-/re-connection on soft and hard tissue changes at implants with platform-switching. J Clin Periodontol. 2012 Aug;39(8):774-80. doi: 10.1111/j.1600-051X.2012.01911.x. Epub 2012 Jun 7. — View Citation

Canullo L, Bignozzi I, Cocchetto R, Cristalli MP, Iannello G. Immediate positioning of a definitive abutment versus repeated abutment replacements in post-extractive implants: 3-year follow-up of a randomised multicentre clinical trial. Eur J Oral Implantol. 2010 Winter;3(4):285-96. — View Citation

Iglhaut G, Becker K, Golubovic V, Schliephake H, Mihatovic I. The impact of dis-/reconnection of laser microgrooved and machined implant abutments on soft- and hard-tissue healing. Clin Oral Implants Res. 2013 Apr;24(4):391-7. doi: 10.1111/clr.12040. Epub 2012 Sep 26. — View Citation

Lazzara RJ, Porter SS. Platform switching: a new concept in implant dentistry for controlling postrestorative crestal bone levels. Int J Periodontics Restorative Dent. 2006 Feb;26(1):9-17. — View Citation

Pieri F, Aldini NN, Marchetti C, Corinaldesi G. Influence of implant-abutment interface design on bone and soft tissue levels around immediately placed and restored single-tooth implants: a randomized controlled clinical trial. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):169-78. — View Citation

Rodriguez X, Vela X, Mendez V, Segala M, Calvo-Guirado JL, Tarnow DP. The effect of abutment dis/reconnections on peri-implant bone resorption: a radiologic study of platform-switched and non-platform-switched implants placed in animals. Clin Oral Implants Res. 2013 Mar;24(3):305-11. doi: 10.1111/j.1600-0501.2011.02317.x. Epub 2011 Oct 3. — View Citation

Tarnow DP, Cho SC, Wallace SS. The effect of inter-implant distance on the height of inter-implant bone crest. J Periodontol. 2000 Apr;71(4):546-9. doi: 10.1902/jop.2000.71.4.546. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-implant marginal bone level change.	To estimate the gingival margin stability and the long-term success of implant-supported restorations, the peri-implant marginal bone level will be assessed as primary outcome through intraoral radiographs, in a perspective of bone maintenance, bone loss or bone gain.	2, 6, 12 and 24 months after implant surgery.
Secondary	Implant stability change.	The implant stability will be measured using a resonance frequency analysis equipment to confirm the implant osseointegration.	3 and 6 months after implant surgery.
Secondary	Gingival level change.	The gingival level will be measured using a periodontal probe and an acrylic stent as a reference.	6, 12 and 24 months after implant surgery.
Secondary	Peri-implant probing depth change.	To evaluate the peri-implant health, the probing depth will be assessed in 6 areas around the implant using the prosthetic abutment as a reference.	12 and 24 months after implant surgery.
Secondary	Bleeding on probing change.	To evaluate the peri-implant health, the bleeding on probing will be observer or not at until 10 seconds after peri-implant probing.	12 and 24 months after implant surgery.