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NCT Number: NCT05533528

Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

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).

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Key information

Conditions

Periodontal Pocket Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Bone Loss Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Periodontal surgery

Procedure

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.

Primary outcomes

  1. Clinical attachment gain (CAG)

    Time frame: 12 months

    Clinical attachment gain

Secondary outcomes

  1. rPD

    Time frame: 12 months

    residual probing depth

  2. PPDr

    Time frame: 12 months

    Probing pocket depth reduction

  3. iGR

    Time frame: 12 months

    interproximal gingival recession

  4. Early Healing Index (EHI)

    Time frame: 1 week

    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.

  5. SUPRA-AG

    Time frame: 12 months

    Supra-alveolar attachment gain

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio J Ortiz-Ruiz, MD

CONTACT

[email protected]

+34 868888581

José A Moreno-Rodríguez, DDS

CONTACT

[email protected]

+34 620538483

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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