Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: periodontal surgery.
- Who it may be relevant to
- Registry conditions: Periodontal Pocket, Periodontal Diseases, Periodontal Bone Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. A Randomized Clinical Trial
Overview
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).
Interventions
- Procedure periodontal 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 ca
Primary outcome measures
- Clinical attachment gain (CAG) [Time frame: 12 months]
Secondary outcome measures (5)
- rPD [Time frame: 12 months]
- PPDr [Time frame: 12 months]
- iGR [Time frame: 12 months]
- Early Healing Index (EHI) [Time frame: 1 week]
- SUPRA-AG [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Centro Odontologico Del Sureste Slp — Murcia
Identifiers
NCT: NCT05533528 · 3111/2020