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Influence of Flap Position Following FibReORS

Primary Purpose

Periodontitis, Periodontal Diseases

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

FibReORS with apically positioned flap (apical position)

FibReORS with apically positioned flap (crestal position)

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, flap position, soft tissue regrowth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

C.I.R. Dental School. Università di Torino

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

apical group

Crestal group

Arm Description

FibReORS with apically flap positioning 2 mm below the bone crest (apical group)

FibReORS with apically flap positioning at the level of bone crest (crestal group).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05140681

First Posted

November 18, 2021

Last Updated

November 18, 2021

Sponsor

University of Turin, Italy

1. Study Identification

Unique Protocol Identification Number

NCT05140681

Brief Title

Influence of Flap Position Following FibReORS

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

October 31, 2018 (Actual)

Study Completion Date

December 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Turin, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis, Periodontal Diseases

Keywords

periodontitis, flap position, soft tissue regrowth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

apical group

Arm Type

Experimental

Arm Description

FibReORS with apically flap positioning 2 mm below the bone crest (apical group)

Arm Title

Crestal group

Arm Type

Active Comparator

Arm Description

FibReORS with apically flap positioning at the level of bone crest (crestal group).

Intervention Type

Procedure

Intervention Name(s)

FibReORS with apically positioned flap (apical position)

Intervention Description

Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at 2 mm subcrestal position

Intervention Type

Procedure

Intervention Name(s)

FibReORS with apically positioned flap (crestal position)

Intervention Description

Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at either a crestal position

Primary Outcome Measure Information:

Title

Amount of soft tissue re-growth after FibReORS

Description

The amount of regrowth is calculated from the position of the tissue at the end of the surgery

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Amount of KT increase after FibReORS

Description

The amount of KT increase is calculated from the position of the tissue at the end of the surgery

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

C.I.R. Dental School. Università di Torino

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

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Influence of Flap Position Following FibReORS

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