Reconstructive Surgical ProcedureNCT04376450
Nonincised Papillae in the Treatment of Intrabony Defects.
A study testing Experimental- Nonincised papillae surgical approach and Active comparator- Entire papilla preservation technique in people with Reconstructive Surgical Procedure, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Reconstructive Surgical Procedure
- What is being tested?
- Experimental- Nonincised papillae surgical approach and Active comparator- Entire papilla preservation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- 6 Mar 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.
- Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.
- Adequate attached gingiva of 3mm and vestibular depth of 8mm. -
Who cannot join
- Uncontrolled systemic disease.
- Pregnancy and lactation.
- Defects involving lingual sites.
- Presence of restoration in the experimental teeth.
- Smokers -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
R V Chandra
Hyderabad, Telangana, 509002
R V Chandra, MDS;DNB;PhD, 9908183071, viswachandra@hotmail.com
About this study
Official title: A Comparative Evaluation of Nonincised Papillae and Entire Papilla Preservation Surgical Approach in the Treatment of Intrabony Defects - a Clinical and Radiographic Study
The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.
Read the detailed description
Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession.
In order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.
- Conditions
- Reconstructive Surgical Procedure
- Being tested
- Experimental- Nonincised papillae surgical approach, Active comparator- Entire papilla preservation technique
- Keywords
- Periodontitis; reconstructive surgical procedure;, guided tissue regeneration;, surgical flaps;treatment outcome
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental- Nonincised papillae surgical approachProcedure or surgery
Also called NIPSA
The basic principle of the technique is the placement of only one buccal horizontal or oblique incision in the mucosa, as apically as possible from the periodontal defect and the marginal tissues, and the raising of a mucoperiosteal flap coronally, which permits apical access to the defect but leaving the marginal tissues intact, acting as a "dome" for the protection of the clot.
Active comparator- Entire papilla preservation techniqueProcedure or surgery
Also called EPP
The entire Papilla Preservation Technique is to preserve the whole integrity of the defect- associated papilla providing a tunnel-like undermining incision. The completely preserved interdental papilla provides an intact gingival chamber to stabilize the blood clot and improve the wound healing process. To provide adequate access for debridement, EPP requires a short buccal vertical releasing incision on the buccal side of the neighboring tooth extending just beyond the mucogingival line.
| Study group | Role | What they receive |
|---|---|---|
| Nonincised Papillae Surgical Approach | Experimental | Nonincised papillae surgical approach is a papillae preservation technique, where an apical approach is carried out, without incisions or disinsertion of tissues at the level of the papillae or marginal tissues. Receives: Procedure: Experimental- Nonincised papillae surgical approach |
| Entire Papilla Preservation Technique | Active comparator | Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla Receives: Procedure: Active comparator- Entire papilla preservation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICAL ATTACHMENT LEVEL (CAL)
measured from the cemento-enamel junction (CEJ) to the bottom of the pocket
Measured: Baseline to 6 months
POCKET PROBING DEPTH (PPD)
from the gingival margin to the bottom of the pocket;
Measured: Baseline to 6 months
Intrabony component (INTRA) of the defect
the distance from the most coronal extension of the interdental bone crest (BC) to the bottom of the defect (BD) (BC-BD).
Measured: Baseline to 6 months
Secondary outcomes (2)
Papilla loss (PL)
measured from contact point to tip of the papilla.
Measured: Baseline to 6 months
Local bleeding score
recorded as positive when bleeding on probing was present at the surgical site.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start6 Mar 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgical ProcedureStudies 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
- Model description
- GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376450
- Sponsor's protocol ID
- SVSIDS/PERIO/2/2018
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Nonincised Papillae and Entire Papilla Preservation Surgical Approach in the Treatment of Intrabony Defects - a Clinical and Radiographic Study
- ClinicalTrials.gov ID
- NCT04376450
- Acronym / sponsor ID
- SVSIDS/PERIO/2/2018
- Conditions
- Reconstructive Surgical Procedure
- Keywords
- Periodontitis; reconstructive surgical procedure;, guided tissue regeneration;, surgical flaps;treatment outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 May 2020 (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.
The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.
Detailed description
Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession.
In order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)
| Arm | Type | Receives |
|---|---|---|
| Nonincised Papillae Surgical Approach | Experimental | Procedure: Experimental- Nonincised papillae surgical approachNonincised papillae surgical approach is a papillae preservation technique, where an apical approach is carried out, without incisions or disinsertion of tissues at the level of the papillae or marginal tissues. |
| Entire Papilla Preservation Technique | Active comparator | Procedure: Active comparator- Entire papilla preservation techniqueEntire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.
- Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.
- Adequate attached gingiva of 3mm and vestibular depth of 8mm. -
Key exclusion criteria (5 listed)
- Uncontrolled systemic disease.
- Pregnancy and lactation.
- Defects involving lingual sites.
- Presence of restoration in the experimental teeth.
- Smokers -
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 |
|---|---|---|
| Experimental- Nonincised papillae surgical approachAlso: NIPSAThe basic principle of the technique is the placement of only one buccal horizontal or oblique incision in the mucosa, as apically as possible from the periodontal defect and the marginal tissues, and the raising of a mucoperiosteal flap coronally, which permits apical access to the defect but leaving the marginal tissues intact, acting as a "dome" for the protection of the clot. | Procedure or surgery | Nonincised Papillae Surgical Approach |
| Active comparator- Entire papilla preservation techniqueAlso: EPPThe entire Papilla Preservation Technique is to preserve the whole integrity of the defect- associated papilla providing a tunnel-like undermining incision. The completely preserved interdental papilla provides an intact gingival chamber to stabilize the blood clot and improve the wound healing process. To provide adequate access for debridement, EPP requires a short buccal vertical releasing incision on the buccal side of the neighboring tooth extending just beyond the mucogingival line. | Procedure or surgery | Entire Papilla Preservation Technique |
Primary outcome
CLINICAL ATTACHMENT LEVEL (CAL)
Time frame: Baseline to 6 months
measured from the cemento-enamel junction (CEJ) to the bottom of the pocket
POCKET PROBING DEPTH (PPD)
Time frame: Baseline to 6 months
from the gingival margin to the bottom of the pocket;
Intrabony component (INTRA) of the defect
Time frame: Baseline to 6 months
the distance from the most coronal extension of the interdental bone crest (BC) to the bottom of the defect (BD) (BC-BD).
2 secondary outcomes
Papilla loss (PL)
Time frame: Baseline to 6 months
Local bleeding score
Time frame: Baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental- Nonincised papillae surgical approach and Active comparator- Entire papilla preservation technique in people with Reconstructive Surgical Procedure, run by SVS Institute of Dental Sciences at 1 site in India.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 May 2020. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R V Chandra, MDS;DNB;PhD (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICAL ATTACHMENT LEVEL (CAL) (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.