Influence of Flap Position Following FibReORS

Periodontitis Clinical Trial

Official title:

Influence of Flap Position on Soft Tissue Regrowth, Keratinized Tissue Increase and Postoperative Discomfort Following Fibre Retention Osseous Resective Surgery (FibReORS): a 6-month Split-mouth RCT With Multilevel Analysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140681
• Other study ID #: FibReORSTurin
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 23, 2018

Study information

• Verified date: November 2021
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is lack of data in literature on keratinized tissue increase after FibReORS in relation to primary flap position. This study has been designed as a split-mouth randomized trial to assess the influence of flap position after FibReORS. 16 patients were recruited and treated. The placement of the flap 2 mm apically to the bone crest instead at the bone level would be a viable approach to increase KT width without delaying wound healing. The extent of post-operative discomfort/pain was not influenced by primary flap position.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 23, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1) diagnosis of severe chronic periodontitis (corresponding to grade III or IV according to the actual classification); 2) good general health; 3) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 20%; 4) at least two contralateral sextants with residual PDs of > 5 mm and persisting bleeding on probing (BoP) at posterior natural teeth 3 months after the completion of cause-related therapy

Exclusion Criteria:

1) pregnancy and lactation; 2) smoking > 10 cigarettes/day; 3) intake of antibiotics in the previous 6 months. In addition, teeth with degree II or III mobility, horizontal bone loss higher than 1/3 of the root length or designed as abutment for prosthetic rehabilitation were also excluded from the study.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• FibReORS with apically positioned flap (apical position)
Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at 2 mm subcrestal position
• FibReORS with apically positioned flap (crestal position)
Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at either a crestal position

Locations

Country	Name	City	State
Italy	C.I.R. Dental School. Università di Torino	Torino	TO

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of soft tissue re-growth after FibReORS	The amount of regrowth is calculated from the position of the tissue at the end of the surgery	6 months
Secondary	Amount of KT increase after FibReORS	The amount of KT increase is calculated from the position of the tissue at the end of the surgery	6 months