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

NCT02617212 | Completed DMC

• 1 other identifier: 1.310.562
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Loss

Keywords

dental implant; bone preservation; definitive abutment; one abutment one time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Implant stability change.

  3 and 6 months after implant surgery.

• Gingival level change.

  6, 12 and 24 months after implant surgery.

• Peri-implant probing depth change.

  12 and 24 months after implant surgery.

• Bleeding on probing change.

  12 and 24 months after implant surgery.

Study Arms (2)

Definitive abutment

EXPERIMENTAL

Implant surgery. No abutment dis-/reconnections.

Procedure: Implant surgery; Device: No abutment dis-/reconnections.

Conventional treatment

ACTIVE COMPARATOR

Implant surgery. Three abutment dis-/reconnections.

Procedure: Implant surgery; Device: Three abutment dis-/reconnections.

Interventions

Implant surgery PROCEDURE

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.

Conventional treatment; Definitive abutment

Three abutment dis-/reconnections. DEVICE

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.

Conventional treatment

No abutment dis-/reconnections. DEVICE

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.

Definitive abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Diabetes mellitus;
• Treatment with bisphosphonates;
• Head and neck irradiation;
• General contraindications to oral surgery;
• Pregnancy;
• Bone graft;
• Bruxism;
• Smoking habits.

Sponsors & Collaborators

• Fortaleza University: lead
• Universidade Federal do Ceara: collaborator

Study Sites (1)

Fortaleza University; Health Sciences Center; School of Dentistry.

Fortaleza, Ceará, 60811-905, Brazil

Location

Related Publications (10)

• 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.

  PMID: 6809663 BACKGROUND

• 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.

  PMID: 3527955 BACKGROUND

• 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.

  PMID: 9266344 BACKGROUND

• 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.

  PMID: 10807116 BACKGROUND

• 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.

  PMID: 16515092 BACKGROUND

• 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.

  PMID: 21180681 BACKGROUND

• 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.

  PMID: 21365053 BACKGROUND

• 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.

  PMID: 22676071 BACKGROUND

• 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.

  PMID: 22092773 BACKGROUND

• 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.

  PMID: 23009248 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Rodrigo O. Rego, PhD

  Universidade Federal do Ceara

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 30, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)