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Influence of Flap Position Following FibReORS

NCT ID: NCT05140681

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-12-23

Brief Summary

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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

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Conditions

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Periodontitis Periodontal Diseases

Keywords

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periodontitis flap position soft tissue regrowth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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apical group

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

Group Type EXPERIMENTAL

FibReORS with apically positioned flap (apical position)

Intervention Type PROCEDURE

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

Crestal group

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

Group Type ACTIVE_COMPARATOR

FibReORS with apically positioned flap (crestal position)

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Mario Aimetti

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Torino, TO, Italy

Site Status

Countries

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Italy

References

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Piccoli GM, Romano F, Giraudi M, La Bruna N, Citterio F, Mariani GM, Baima G, Aimetti M. Effect of post-surgical flap position on soft tissue regrowth and keratinized tissue increase following fibre retention osseous resective surgery: a 6-month randomized study with multilevel analysis. BMC Oral Health. 2023 Jul 10;23(1):472. doi: 10.1186/s12903-023-03144-2.

Reference Type DERIVED
PMID: 37430291 (View on PubMed)

Other Identifiers

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FibReORSTurin

Identifier Type: -

Identifier Source: org_study_id