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OpenTrials
Completed

NCT Number: NCT05140681

Influence of Flap Position Following FibReORS

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Torino, TO, 10126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

FibReORS with apically positioned flap (apical position)

Procedure

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)

Procedure

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

Primary outcomes

  1. Amount of soft tissue re-growth after FibReORS

    Time frame: 6 months

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

Secondary outcomes

  1. Amount of KT increase after FibReORS

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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