Molecular Content of Peri-implant Sulcus During Wound Healing and Osseointegration Following Drilling and Piezosurgery

NCT03538184 | Completed DMC

• 1 other identifier: BAP 2013 Dent 009
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the levels of cytokines, chemokines and growth factors in peri-implant sulcular fluid (PISF) during healing and osseointegration at osteotomy sites prepared either with piezosurgery (PS) or drills (D). Fourteen patients having bilateral partial edentulism in the posterior maxilla were enrolled and 38 osteotomies were prepared. Implants were placed with one-stage surgery. Insertion torque, early healing index, probing depth and modified gingival and plaque indices and crestal bone (CB) loss were measured. PISF was collected from 4 sites from each implant at weeks 2, 4, 8, 12 and 24. PISF samples were analysed by a 30-Plex immunoassay. Effect of time and osteotomy method on molecules employed Brunner-Langer method.

Conditions

Tooth Loss; Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Radiological bone levels at 12th and 24th weeks (Change from Baseline)

  Bone Loss (measured distance from implant shoulder to first bone to implant contact on periodical radiographs and computerised cone beam tomography

  Baseline (implant placement), 12th and 24th weeks after implant placement

Secondary Outcomes (26)

• IL-1beta content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week)

  2nd,4th, 8th, 12th and 24th weeks

• G.CSF content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week)

  2nd,4th, 8th, 12th and 24th weeks

• IL-13 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week)

  2nd,4th, 8th, 12th and 24th weeks

• IL-6 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week)

  2nd,4th, 8th, 12th and 24th weeks

• IL-12 content of peri implant sulcus fluid at 4th, 8th, 12th and 24th weeks (Change from 2nd week)

  2nd,4th, 8th, 12th and 24th weeks

Study Arms (2)

Piezosurgery

EXPERIMENTAL

Osteotomy preparation entirely with piezosurgery tips and equicrestal placement of a 4.1 mm implant in the piezosurgery (test) group were performed as follows: 1.15 mm initial MB1 tip, 1.95 mm MB2 tip, control of depth, diameter and direction of osteotomy with 2.0 mm paralleling pin, 2.5 mm MB3 tip, 2.8 mm MB4 tip, 2.8 mm paralleling pin, 3.05 mm MB5 tip, 3.3 mm MB6 tip, control of final diameter of the osteotomy with 3.5 mm paralleling pin, placement of the 4.1 mm diameter implant and connection of a 4 mm-wide healing abutment.

Procedure: Piezosurgery

Drill

ACTIVE COMPARATOR

Preparation of an implant recipient site entirely with relevant drills were performed as follows: Osteotomy preparation and equicrestal placement of a 4.1 mm diameter implant in the drill (control) group were performed as follows: initial trispade drill, 2.0 mm pilot drill, control of depth, diameter and direction of osteotomy with 2.0 mm paralleling pin, 2.5 mm drill, 2.8 mm drill, 2.8 mm paralleling pin, 3.5 mm drill, control of final diameter of the osteotomy with 3.5 mm paralleling pin, placement of the 4.1 mm diameter implant and connection of a 4 mm wide healing abutment.

Procedure: Drill

Interventions

Piezosurgery PROCEDURE

Preparation of implant beds entirely with piezo surgery implant tips

Piezosurgery

Drill PROCEDURE

Preparation of implant beds entirely with conventional implant drills

Drill

Eligibility Criteria

• Age: 31 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Bilateral partial edentulism in posterior maxilla
• \>8 mm available bone height (distance between bone crest and maxillary sinus) and ≥7 mm bone width
• At least 2 mm buccal keratinized mucosa width and 3 mm mucosa thickness.

You may not qualify if:

• Diseases and conditions or medications which may negatively influence biological dynamics of bone and wound healing
• Ridge deficiencies requiring additional augmentation
• Indication of sinus lifting with crestal or lateral approach

Sponsors & Collaborators

• Ege University: lead

Related Publications (12)

• Berglundh T, Abrahamsson I, Lang NP, Lindhe J. De novo alveolar bone formation adjacent to endosseous implants. Clin Oral Implants Res. 2003 Jun;14(3):251-62. doi: 10.1034/j.1600-0501.2003.00972.x.

  PMID: 12755774 RESULT

• Berglundh T, Abrahamsson I, Welander M, Lang NP, Lindhe J. Morphogenesis of the peri-implant mucosa: an experimental study in dogs. Clin Oral Implants Res. 2007 Feb;18(1):1-8. doi: 10.1111/j.1600-0501.2006.01380.x.

  PMID: 17224016 RESULT

• Tomasi C, Tessarolo F, Caola I, Wennstrom J, Nollo G, Berglundh T. Morphogenesis of peri-implant mucosa revisited: an experimental study in humans. Clin Oral Implants Res. 2014 Sep;25(9):997-1003. doi: 10.1111/clr.12223. Epub 2013 Jun 26.

  PMID: 23799997 RESULT

• Tomasi C, Tessarolo F, Caola I, Piccoli F, Wennstrom JL, Nollo G, Berglundh T. Early healing of peri-implant mucosa in man. J Clin Periodontol. 2016 Oct;43(10):816-24. doi: 10.1111/jcpe.12591. Epub 2016 Jul 28.

  PMID: 27329966 RESULT

• Insua A, Monje A, Wang HL, Miron RJ. Basis of bone metabolism around dental implants during osseointegration and peri-implant bone loss. J Biomed Mater Res A. 2017 Jul;105(7):2075-2089. doi: 10.1002/jbm.a.36060. Epub 2017 Mar 28.

  PMID: 28281321 RESULT

• Esteves JC, Marcantonio E Jr, de Souza Faloni AP, Rocha FR, Marcantonio RA, Wilk K, Intini G. Dynamics of bone healing after osteotomy with piezosurgery or conventional drilling - histomorphometrical, immunohistochemical, and molecular analysis. J Transl Med. 2013 Sep 23;11:221. doi: 10.1186/1479-5876-11-221.

  PMID: 24053147 RESULT

• Preti G, Martinasso G, Peirone B, Navone R, Manzella C, Muzio G, Russo C, Canuto RA, Schierano G. Cytokines and growth factors involved in the osseointegration of oral titanium implants positioned using piezoelectric bone surgery versus a drill technique: a pilot study in minipigs. J Periodontol. 2007 Apr;78(4):716-22. doi: 10.1902/jop.2007.060285.

  PMID: 17397320 RESULT

• Peker Tekdal G, Bostanci N, Belibasakis GN, Gurkan A. The effect of piezoelectric surgery implant osteotomy on radiological and molecular parameters of peri-implant crestal bone loss: a randomized, controlled, split-mouth trial. Clin Oral Implants Res. 2016 May;27(5):535-44. doi: 10.1111/clr.12620. Epub 2015 Jun 16.

  PMID: 26077862 RESULT

• Bielemann AM, Marcello-Machado RM, Leite FRM, Martinho FC, Chagas-Junior OL, Antoninha Del Bel Cury A, Faot F. Comparison between inflammation-related markers in peri-implant crevicular fluid and clinical parameters during osseointegration in edentulous jaws. Clin Oral Investig. 2018 Jan;22(1):531-543. doi: 10.1007/s00784-017-2169-0. Epub 2017 Jul 14.

  PMID: 28710652 RESULT

• Chien HH, Meng HW, Gross AC, Eubank TD, Yildiz VO, Leblebicioglu B. The Effect of Platform Switching on Periimplant Crevicular Fluid Content During Early Wound Healing. Implant Dent. 2016 Oct;25(5):629-37. doi: 10.1097/ID.0000000000000463.

  PMID: 27504534 RESULT

• Emecen-Huja P, Eubank TD, Shapiro V, Yildiz V, Tatakis DN, Leblebicioglu B. Peri-implant versus periodontal wound healing. J Clin Periodontol. 2013 Aug;40(8):816-24. doi: 10.1111/jcpe.12127. Epub 2013 Jun 18.

  PMID: 23772674 RESULT

• Sculean A, Gruber R, Bosshardt DD. Soft tissue wound healing around teeth and dental implants. J Clin Periodontol. 2014 Apr;41 Suppl 15:S6-22. doi: 10.1111/jcpe.12206.

  PMID: 24641001 RESULT

MeSH Terms

Conditions

Tooth Loss; Jaw, Edentulous

Interventions

Piezosurgery; Plyometric Exercise

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Jaw Diseases; Musculoskeletal Diseases; Mouth, Edentulous

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 29, 2018
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share