PeriodontitisNCT03997552
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
A study testing Non-incised papillae surgical approach (NIPSA), marginal approach by palatal incision and Minimally invasive surgical technique (MIST) in people with Periodontitis and Periodontal Diseases, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- What is being tested?
- Non-incised papillae surgical approach (NIPSA), marginal approach by palatal incision and Minimally invasive surgical technique (MIST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 6 Sep 2019to 1 Feb 2027
- 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
- patients diagnosed with periodontitis.
- plaque index and bleeding index of < 30%.
- periodontal lesions with pocket probing depth > 5 mm.
- intrabony defect > 3 mm.
- intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.
Who cannot join
- patients with systemic diseases that contraindicated treatment.
- third molars.
- teeth with incorrect endodontic or restorative treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centro Odontologico Del Sureste Slp
Murcia, 30007
Antonio J Ortiz-Ruiz, MD, +34 868888581, ajortiz@um.es
Jose A Moreno-Rodriguez, +34 620538483, joseantonio171087@hotmail.com
About this study
Official title: Non-Incised Papillae Surgical Approach (NIPSA) Versus Marginal Approach by Palatal Incision and Minimally Invasive Surgical Technique (MIST) in Periodontal Regeneration: a Ramdomized Clinical Trial
Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.
- Conditions
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- Being tested
- Non-incised papillae surgical approach (NIPSA), marginal approach by palatal incision, Minimally invasive surgical technique (MIST)
- Medical subject headings
- Periodontitis, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-incised papillae surgical approach (NIPSA)Procedure or surgery
Periodontal reconstructive surgery
marginal approach by palatal incisionProcedure or surgery
Periodontal reconstructive surgery
Minimally invasive surgical technique (MIST)Procedure or surgery
Periodontal reconstructive surgery
| Study group | Role | What they receive |
|---|---|---|
| Non-incised papillae surgical approach (NIPSA) | Experimental | To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesiodistally as necessary to allow access to the defect and correct debridement of the granulation tissue. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. Receives: Procedure: Non-incised papillae surgical approach (NIPSA) |
| marginal approach by palatal incision | Active comparator | A small incision in the palatal aspect and a limited papila elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces. Receives: Procedure: marginal approach by palatal incision |
| Minimally invasive surgical technique (MIST) | Active comparator | The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures. Receives: Procedure: Minimally invasive surgical technique (MIST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PD)
Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
Measured: 12 months
Clinical attachment level (CAL)
Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.
Measured: 12 months
Recession (REC)
Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Measured: 12 months
Location of the tip of the papillae (TP)
Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise.
This outcome will be assessed with a periodontal probe and measured in mmm.
Measured: 12 months
Keratinized tissue width (KT)
Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
Measured: 12 months
Bleeding on probing
Bleeding on probing could be positive or negative.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start6 Sep 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio José Ortiz Ruiz, MD, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997552
- Sponsor's protocol ID
- 2409/2019
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
PubMed 30421495Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
PubMed 31190409
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Incised Papillae Surgical Approach (NIPSA) Versus Marginal Approach by Palatal Incision and Minimally Invasive Surgical Technique (MIST) in Periodontal Regeneration: a Ramdomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03997552
- Acronym / sponsor ID
- 2409/2019
- Conditions
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-incised papillae surgical approach (NIPSA) | Experimental | Procedure: Non-incised papillae surgical approach (NIPSA)To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesiodistally as necessary to allow access to the defect and correct debridement of the granulation tissue. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the enamel matrix derivates will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures. |
| marginal approach by palatal incision | Active comparator | Procedure: marginal approach by palatal incisionA small incision in the palatal aspect and a limited papila elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces. |
| Minimally invasive surgical technique (MIST) | Active comparator | Procedure: Minimally invasive surgical technique (MIST)The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients diagnosed with periodontitis.
- plaque index and bleeding index of < 30%.
- periodontal lesions with pocket probing depth > 5 mm.
- intrabony defect > 3 mm.
- intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.
Key exclusion criteria (3 listed)
- patients with systemic diseases that contraindicated treatment.
- third molars.
- teeth with incorrect endodontic or restorative treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-incised papillae surgical approach (NIPSA)Periodontal reconstructive surgery | Procedure or surgery | Non-incised papillae surgical approach (NIPSA) |
| marginal approach by palatal incisionPeriodontal reconstructive surgery | Procedure or surgery | marginal approach by palatal incision |
| Minimally invasive surgical technique (MIST)Periodontal reconstructive surgery | Procedure or surgery | Minimally invasive surgical technique (MIST) |
Primary outcome
Probing pocket depth (PD)
Time frame: 12 months
Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket
Clinical attachment level (CAL)
Time frame: 12 months
Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.
Recession (REC)
Time frame: 12 months
Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Location of the tip of the papillae (TP)
Time frame: 12 months
Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mmm.
Keratinized tissue width (KT)
Time frame: 12 months
Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
Bleeding on probing
Time frame: 12 months
Bleeding on probing could be positive or negative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 30421495Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
- Results publication: PubMed 31190409Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-incised papillae surgical approach (NIPSA), marginal approach by palatal incision and Minimally invasive surgical technique (MIST) in people with Periodontitis and Periodontal Diseases, run by Universidad de Murcia at 1 site in Spain.
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 5 inclusion and 3 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 17 Feb 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 Spain. 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 Antonio J Ortiz-Ruiz, MD (+34 868888581, ajortiz@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (PD) (time frame: 12 months). The study lists 6 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 NCT03997552, which also lists 2 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 17 Feb 2026.