Influence of Flap Position Following FibReORS

Not Applicable

Completed

• Conditions: Periodontitis; Periodontal Diseases
• Interventions: Procedure: FibReORS with apically positioned flap (apical position); Procedure: FibReORS with apically positioned flap (crestal position)

• Registration Number: NCT05140681
• Lead Sponsor: University of Turin, Italy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-23
• Status Verified: 2021-11
• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
apical group	FibReORS with apically positioned flap (apical position)	FibReORS with apically flap positioning 2 mm below the bone crest (apical group)
Crestal group	FibReORS with apically positioned flap (crestal position)	FibReORS with apically flap positioning at the level of bone crest (crestal group).

Primary Outcome Measures

Name	Time	Method
Amount of soft tissue re-growth after FibReORS	6 months	The amount of regrowth is calculated from the position of the tissue at the end of the surgery

Secondary Outcome Measures

Name	Time	Method
Amount of KT increase after FibReORS	6 months	The amount of KT increase is calculated from the position of the tissue at the end of the surgery

Trial Locations

Locations (1)

C.I.R. Dental School. Università di Torino; 🇮🇹 Torino, TO, Italy