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Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

U

Universidad de Murcia

Status

Enrolling

Conditions

Periodontal Pocket
Periodontal Diseases
Periodontal Bone Loss

Treatments

Procedure: periodontal surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05533528
3111/2020

Details and patient eligibility

About

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).

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

25 participants in 2 patient groups

Control
Active Comparator group
Description:
Access flap periodontal surgery
Treatment:
Procedure: periodontal surgery
Test
Experimental group
Description:
Access flap periodontal surgery and periodontal granulation tissue debridement.
Treatment:
Procedure: periodontal surgery

Trial contacts and locations

1

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Central trial contact

José A Moreno-Rodríguez, DDS; Antonio J Ortiz-Ruiz, MD

Data sourced from clinicaltrials.gov

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