Influence of Flap Position Following FibReORS

Study Overview
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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.

Official Title
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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.

Conditions
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Periodontitis, Periodontal Diseases

Intervention / Treatment
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* Procedure: FibReORS with apically positioned flap (apical position)
* Procedure: FibReORS with apically positioned flap (crestal position)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apical group<br>FibReORS with apically flap positioning 2 mm below the bone crest (apical group) | Procedure: FibReORS with apically positioned flap (apical position)<br>* Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at 2 mm subcrestal position<br>|
| Active Comparator: Crestal group<br>FibReORS with apically flap positioning at the level of bone crest (crestal group). | Procedure: FibReORS with apically positioned flap (crestal position)<br>* Periodontal surgery including flap elevation. root surface scaling, bone remodeling and suture of the flap at either a crestal position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, flap position, soft tissue regrowth