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Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

ConditionsPeriodontal PocketPeriodontal DiseasesPeriodontal Bone Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Murcia

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Systemic disease contraindicating periodontal surgery.

Teeth with incorrect endodontic treatment or restoration.

Stage I or II periodontitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • periodontal surgery

    Procedure/Surgery

    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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TestExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical attachment gain (CAG)

Clinical attachment gain

Time frame
12 months

Secondary outcomes

1

rPD

residual probing depth

Time frame
12 months
2

PPDr

Probing pocket depth reduction

Time frame
12 months
3

iGR

interproximal gingival recession

Time frame
12 months
4

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.

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Murcia

Lead sponsor

Source ClinicalTrials.gov
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