Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

Study Overview
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Brief Summary
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The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential. The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue). Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).

Official Title
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Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial

Conditions
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Periodontal Pocket, Periodontal Diseases, Periodontal Bone Loss

Intervention / Treatment
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* Procedure: periodontal surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage III or IV periodontitis, including all grades. Unresolved deep pockets (probing pocket depth [PPD] >5 mm + BoP) 4 to 6 weeks after non-surgical treatment. Interproximal plaque index <35% maintained during periodontal treatment and maintenance. Adherence to periodontal maintenance appointments. Exclusion Criteria: Systemic disease contraindicating periodontal surgery. Teeth with incorrect endodontic treatment or restoration. Stage I or II periodontitis.

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Access flap periodontal surgery | Procedure: periodontal surgery<br>* A sulcular incision will be made in the affected teeth, followed by an incision from the buccal aspect in the mid-portion of the interproximal tissues The buccal and lingual flaps will be elevated. For periodontal granulation tissue preservation group, the soft tissues covering the alveolar crest will be prepared. A third incision will separate the pocket epithelium from the soft tissue (granulation tissue) attached to the bone. The pocket epithelium will be removed. The root surfaces will be carefully scaled and planed in both groups. Ethylenediaminetetraacetic acid (24%) will be applied to the root surfaces and removed after 2 minutes with abundant saline solution. In the experimental group, the preserved attached soft tissue and the space between it and the root surface will be irrigated with 10% polyvinylpyrrolidone-iodine. Finally, the flaps will be positioned and sutured.<br>|
| Experimental: Test<br>Access flap periodontal surgery and periodontal granulation tissue debridement. | Procedure: periodontal surgery<br>* A sulcular incision will be made in the affected teeth, followed by an incision from the buccal aspect in the mid-portion of the interproximal tissues The buccal and lingual flaps will be elevated. For periodontal granulation tissue preservation group, the soft tissues covering the alveolar crest will be prepared. A third incision will separate the pocket epithelium from the soft tissue (granulation tissue) attached to the bone. The pocket epithelium will be removed. The root surfaces will be carefully scaled and planed in both groups. Ethylenediaminetetraacetic acid (24%) will be applied to the root surfaces and removed after 2 minutes with abundant saline solution. In the experimental group, the preserved attached soft tissue and the space between it and the root surface will be irrigated with 10% polyvinylpyrrolidone-iodine. Finally, the flaps will be positioned and sutured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment gain (CAG) | Clinical attachment gain | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rPD | residual probing depth | 12 months | 
| PPDr | Probing pocket depth reduction | 12 months | 
| iGR | interproximal gingival recession | 12 months | 
| Early Healing Index (EHI) | Five types of early healing will be recorded: EHI 1, complete closure of the incision line, with no fibrin; EHI 2-3, formation of a thin line or a fibrin clot in the incision area, respectively; EHI 4-5, incomplete closure with partial necrosis or necrosis of the incision area, respectively. | 1 week | 
| SUPRA-AG | Supra-alveolar attachment gain | 12 months |