Regenerative Surgical Treatment of Peri-implant Defects

Implant Site Pocket Infection Clinical Trial

Official title:

Regenerative Surgical Treatment of Peri-implant Defects. Submerged Versus Not Submerged

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440241
• Other study ID #: REGT_CT_19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: University of Santiago de Compostela
• Contact: Santiago Mareque
• Phone: 616 975 256?
• Email: smareque[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high.

Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.

Description:

The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either:

Test group: submerged healing or Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis.

Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years.

• Systemically healthy patients.

• Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth =6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss =3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component.

• Absence of mobility of the implants.

• Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded).

• Patient's smoking = 10 cigarettes/day.

Exclusion Criteria:

• Non-removable prostheses

Related Conditions & MeSH terms

• Implant Site Pocket Infection

Intervention

Procedure:
• regenerative treatment periimplantitis
Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect. The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.

Locations

Country	Name	City	State
Spain	Master Periodoncia. Facultad odontología	Santiago De Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Osteology Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Roccuzzo M, Bonino F, Bonino L, Dalmasso P. Surgical therapy of peri-implantitis lesions by means of a bovine-derived xenograft: comparative results of a prospective study on two different implant surfaces. J Clin Periodontol. 2011 Aug;38(8):738-45. doi: — View Citation

Schwarz F, Herten M, Sager M, Bieling K, Sculean A, Becker J. Comparison of naturally occurring and ligature-induced peri-implantitis bone defects in humans and dogs. Clin Oral Implants Res. 2007 Apr;18(2):161-70. Erratum in: Clin Oral Implants Res. 2007 — View Citation

Schwarz F, Sahm N, Schwarz K, Becker J. Impact of defect configuration on the clinical outcome following surgical regenerative therapy of peri-implantitis. J Clin Periodontol. 2010 May;37(5):449-55. doi: 10.1111/j.1600-051X.2010.01540.x. Epub 2010 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes marginal bone level	measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated.	baseline, 6 and 12 months
Secondary	Changes Probing pocket depth	distance from the margin gingival to the bottom of the peri-implant pouch. All clinical variables will be recorded with a Hu-friedy CP15 UNC millimeter probe in six points on each implant.	baseline, 6 and 12 months
Secondary	Changes Clinical attachment level	Distance from the implant shoulder or prosthetic abutment to the bottom of the peri-implant pocket.	baseline, 6 and 12 months
Secondary	Change Reccesion	distance from the margin of the peri-implant mucosa to the implant / abutment interface.	baseline, 6 and 12 months
Secondary	Change Keratinized mucosa	distance from the gingival margin up to the mucogingival line.	baseline, 6 and 12 months
Secondary	Change blending on probing	Registry of presence of bleeding by binary scale (1 bleed present / 0 bleed absent)	baseline, 6 and 12 months
Secondary	Change supuration	Pus presence register by scale binary (1 present / 0 absent)	baseline, 6 and 12 months
Secondary	Change plaque score	Registration of presence of plaque by binary scale on each surface (1 present / 0 absent), calculating the percentage of total surfaces in which plaque is detected by using a periodontal probe	baseline, 6 and 12 months
Secondary	configuration of the bone defect	Based on the classification of Schwarz et al. (2007)	baseline