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Intrabony Periodontal DefectCSTvsMPPTNCT07919769

A Closed Surgical Technique vs Modified Papilla Preservation Technique

A study testing Access Flap and Close Surgical Technique in people with Intrabony Periodontal Defect and Treatment, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A pioneer periodontal surgical approach employing the closed surgical technique (CST) has been designed to gain access to isolated interdental periodontal defects and retain the soft-tissue architecture. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intrabony Periodontal Defect, Treatment, Residual
What is being tested?
Access Flap and Close Surgical Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGreece
Study dates
1 Oct 2026to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Systematically healthy subjects, not having consumed antibiotics 3 months before surgical periodontal treatment (baseline)
  • Smokers <10 cig/day, former smokers or no smokers
  • Periodontal patients fulfilling non-surgical initial periodontal treatment at least 3 months before surgical periodontal treatment (baseline day) and presenting at least one residual pocket with PPD and CAL ≥6mm and bleeding on probing, located interproximally with intrerdental site ≥2mm.
  • Compliant patients presenting high standards of oral hygiene (full mouth Plaque Index <20%) strictly susceptible in Supportive Periodontal

Who cannot join

  • Untreated active periodontal inflammation
  • Poorly controlled systematic diseases
  • Disorders compromise wound healing
  • Bisphosphonate medications
  • Patients under radiotherapy or chemotherapy
  • Drug-induced gingival hyperplasia
Show all 10Show fewer
  • Pregnancy or lactation
  • Poor compliance during steps 1 and 2 of cause-related periodontal treatment
  • Compromised oral hygiene (full mouth Plaque Index >30%),
  • circumferential bone defect or narrow intrerdental site ≤2mm.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Danae Apatzidou, Professor contact

+30 6934770361

perioapatzidou@yahoo.gr

Theodoros-Filippos Valamvanos, PG Student contact

+30 6957165469

valamvanos.filippos@gmail.com

Greece1 site, 1 recruiting

  • Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology

    Thessaloniki, Greece, 54124

    Danae Apatzidou, Professor, +30 6934770361, perioapatzidou@yahoo.gr

    Theodoros-Filippos Valamvanos, PG Student, +30 6957165469, valamvanos.filippos@gmail.com

    Recruiting

Other trials in Greece

About this study

Official title: Closed Surgical Technique Combined With i-PRF for the Treatment of Isolated Intrabony Periodontal Defects; a Randomized Clinical Trial

A pioneer periodontal surgical approach employing the closed surgical technique (CST) has been designed to gain access to isolated interdental periodontal defects and retain the soft-tissue architecture. This technique is based on a modified tunnelling technique to retract full-thickness gingival flaps from the osseous defect in a closed manner retaining intact the interproximal papilla thus, suturing is not required. A randomized controlled clinical trial will determine the efficacy of the CST combined with i-PRF versus the modified papilla preservation technique (MPPT) combined with i-PRF over a period of 12 months

Read the detailed description

This randomized controlled clinical trial will compare the CST combined with i-PRF over the papilla preservation technique (MPPT) combined with i-PRF to treat isolated interdental defects in terms of gain in clinical attachment levels, radiographic evidence of bone apposition and local reduction of biomarkers (VEGF, OPG, RANKL) over a period of 12 months. For the preparation of i-PRF, 20 mL of venous blood is initially collected from each patient under aseptic conditions. The blood samples are then immediately centrifuged at a relative centrifugal force of 700 × g for 8 minutes.

  1. First visit - initial examination - at least 3 months after initial non-surgical periodontal treatment (Step 1, 2) Update general and dental history Screening of subjects for suitability; Consent form; Randomization of suitable subjects Intra-oral photography Full-mouth charting: Probing pocket depth (PPD), Clinical Attachment Level (CAL), Plaque Index (PI), Bleeding on Probing (BoP), Gingival Recession (Rec) Oral hygiene instructions (soft toothbrush, modified Bass, interdental cleaning) Full mouth supragingival scaling
  2. Second visit - Baseline - T0 Collection of Gingival Crevice Fluid (GCF) using sterilized paper strips. Radiographic examination of the site (Long-cone paralleling technique using a digital sensor attached to a custom-made silicone bite block for reproducible radiographs). Periodontal site-selected clinical assessment. Periodontal surgery (control: MPPT or test: the CST) under local anesthesia. Modification of oral hygiene instructions; post-operative instructions Intra-oral photography
  3. Third visit - T1 (2 weeks post-operatively) Suture removal (only in control group) Wound healing visual monitoring by the Early Healing Index (1-5) Oral hygiene instructions. Intra-oral photography. Questionnaire for subjective feelings and satisfaction
  4. Fourth visit - T2 (6 weeks post-operatively) Oral hygiene instructions. Intra-oral photography. Supragingival plaque removal
  5. Fifth visit - T3 - (3 months post-operatively). Oral hygiene instructions. Intra-oral photography. Supragingival plaque removal
  6. Sixth visit - T4 - Re-evaluation (6 months post-operatively) GCF collection using sterilized paper strips. Periodontal full-mouth charting. Site-selected periodontal clinical assessment; Probing Pocket depth (PPD), Clinical Attachment Level (CAL), Plaque Index (PI), Bleeding on Probing (BoP), Gingival Recession (REC) Radiographic examination of the site. Oral hygiene instructions Intra-oral photography
  7. Seventh visit - T5 - Re-evaluation (12 months post-operatively) GCF collection using sterilized paper strips. Periodontal full-mouth charting. Site-selected periodontal clinical assessment; Probing Pocket depth (PPD), Clinical Attachment Level (CAL), Plaque Index (PI), Bleeding on Probing (BoP), Gingival Recession (REC) Radiographic examination of the site. Oral hygiene instructions Intra-oral photography
Being tested
Access Flap, Close Surgical Technique
Keywords
Interdental periodontal defect, periodontal surgery, papilla preservation, tunnelling technique, closed surgical technique
Medical subject headings
Periodontal Pocket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Access FlapProcedure or surgery

    Procedure/Surgery: Access Flap Intrasulcular incisions at the teeth adjacent to the defect, using the modified papilla preservation technique (MPPT). Granulation tissue is excised and debridement via hand and power-driven instruments follows. Autologous injectable platelet-rich fibrin (i-PRF) is prepared by centrifugation and then injected into the periodontal intrabony defect as an autologous bioactive adjunct to surgical treatment. Flaps are repositioned and papilla are sutured with horizontal internal mattress doubled by a single interrupted interdental suture.

  • Close Surgical TechniqueProcedure or surgery

    Strictly intrasulcular incisions are performed at the teeth adjacent to the defect (mid-buccal to mid-lingual) without incising the interdental papilla. Full thickness gingival flaps, at the base of the papilla, which is retained intact, are elevated in a "closed"-tunneling manner, granting access to the interdental osseous defect. Debridement is performed via power-driven tips and mini curettes, without intentionally excising the granulation tissue that lines the osseous defect. Autologous injectable platelet-rich fibrin (i-PRF) is prepared by centrifugation and then injected into the periodontal intrabony defect as an autologous bioactive adjunct to surgical treatment. Flaps are repositioned by gentle pressure and suturing is not required.

Study groups in NCT07919769
Study groupRoleWhat they receive
Access Flap Surgery combined with i-PRFActive comparatorGroup A Intrasulcular incisions at the teeth adjacent to the defect, using the modified papilla preservation technique (MPPT). Granulation tissue is excised and debridement via hand and power-driven instruments follows. Flaps are repositioned and papilla are sutured with horizontal internal mattress doubled by a single interrupted interdental suture.
Receives: Procedure: Access Flap
Closed Surgical Technique combined with i-PRFExperimentalExperimental: Group B Strictly intrasulcular incisions are performed at the teeth adjacent to the defect (mid-buccal to mid-lingual) without incising the interdental papilla. Full thickness gingival flaps, at the base of the papilla, which is retained intact, are elevated in a "closed"-tunneling manner, granting access to the interdental osseous defect. Debridement is performed via power-driven tips and mini curettes, without intentional excising the granulation tissue that lines the osseous defect. Flaps are repositioned by gentle pressure and suturing is not required.
Receives: Procedure: Close Surgical Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Attachment Level

    Determined by a manual periodontal probe(Hu-Friedy XP-23/QW) by a single examiner at the nearest of 1mm

    Measured: baseline to 12 months

  2. Cementoenamel junction to Bottom of the defect

    Determined on standardized periapical radiographs obtained by the long cone parallel technique

    Measured: baseline to 12 months

Secondary outcomes (5)

  1. Probing Pocket Depth

    Determined by a manual periodontal probe

    Measured: baseline to 12 months

  2. Recession

    Determined by a manual periodontal probe

    Measured: baseline to 12 months

  3. Reduction of biomarkers (VEGF, OPG, RANKL)

    Determined by ELISA in GCF

    Measured: baseline to 12 months

  4. Bleeding on Probing

    Determined by a manual periodontal probe

    Measured: baseline to 12 months

  5. Patient satisfaction and perception

    Determined on questionnaires

    Measured: 2 weeks following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start1 Oct 2026
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Interventional Study Model: Parallel Assignment Randomized controlled clinical trial having 2 parallel intervention arms for surgical treatment (step 3) of interproximal residual defects (PPD≥6mm and BoP)
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919769
Sponsor's protocol ID
AUTh 327/29.04.2026
Acronym
CSTvsMPPT
Status last verified
Nov 2026
First submitted
1 Nov 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Overall data but not on an individual basis will be disclosed and shared

Publications

  • Apatzidou DA, Bakopoulou AA, Kouzi-Koliakou K, Karagiannis V, Konstantinidis A. A tissue-engineered biocomplex for periodontal reconstruction. A proof-of-principle randomized clinical study. J Clin Periodontol. 2021 Aug;48(8):1111-1125. doi: 10.1111/jcpe.13474. Epub 2021 May 14.

    PubMed 33899259

  • Cortellini P, Tonetti MS. A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007 Jan;34(1):87-93. doi: 10.1111/j.1600-051X.2006.01020.x.

    PubMed 17243998

  • Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. doi: 10.1902/jop.1995.66.4.261.

    PubMed 7782979

  • Apatzidou DA, Nile C, Bakopoulou A, Konstantinidis A, Lappin DF. Stem cell-like populations and immunoregulatory molecules in periodontal granulation tissue. J Periodontal Res. 2018 Aug;53(4):610-621. doi: 10.1111/jre.12551. Epub 2018 Apr 23.

    PubMed 29687448

Questions about this trial

What is this clinical trial studying?

A study testing Access Flap and Close Surgical Technique in people with Intrabony Periodontal Defect and Treatment, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danae Apatzidou, Professor (+30 6934770361, perioapatzidou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Attachment Level (time frame: baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07919769, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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