Influence of Flap Position Following FibReORS

NCT05140681 | Completed

• 1 other identifier: FibReORSTurin
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Periodontal Diseases

Keywords

periodontitis; flap position; soft tissue regrowth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amount of KT increase after FibReORS

  6 months

Study Arms (2)

apical group

EXPERIMENTAL

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

Procedure: FibReORS with apically positioned flap (apical position)

Crestal group

ACTIVE COMPARATOR

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

Procedure: FibReORS with apically positioned flap (crestal position)

Interventions

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

apical group

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

Crestal group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

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

Torino, TO, 10126, Italy

Location

Related Publications (1)

• 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.

  PMID: 37430291 DERIVED

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: September 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 23, 2018
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)