Reconstructive SurgeryNCT03899051
PRF and Connective Tissue Graft in Interdental Papilla Reconstruction
A study testing interdental papilla reconstructive surgery with PRF and interdental papilla reconstructive surgery with subepithelial connective tissue graft in people with Reconstructive Surgery, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Interdental papilla deficiency leads to food impaction, problems with phonetics and an unaesthetic appearance. Reconstruction of the deficient papilla is therefore, important. Perusal of available literature reveals only case reports and case series in the reconstruction of interdental papilla using subepithelial… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Reconstructive Surgery
- What is being tested?
- interdental papilla reconstructive surgery with PRF and interdental papilla reconstructive surgery with subepithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2018to 1 Apr 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients in the age range of 18-55 years who are systemically healthy.
- Patients with class I and class II papillary recession according to Nordland and Tarnow's classification.
- Patients who have completed etiological periodontal therapy (full mouth scaling and root planing) with Plaque index (Silness \& Loe) <1, gingival index (Loe \& Silness) <1 and showing adequate compliance and willing to participate in the study.
Who cannot join
- Patients having systemic diseases such as hypertension, diabetes, hyperthyroidism or on medications that influence the outcome of periodontal therapy.
- Presence of open contacts in the maxillary anterior region
- Presence of crowding in the maxillary anterior region.
- Pregnant and lactating women
- Patients with active periodontal disease
- Smokers, tobacco users.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
NISHI TANWAR, MDS, 8368126310, nsh_tanwar@yahoo.co.in
About this study
Official title: Comparative Clinical Evaluation of Platelet Rich Fibrin and Subepithelial Connective Tissue Graft in Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial
Interdental papilla deficiency leads to food impaction, problems with phonetics and an unaesthetic appearance. Reconstruction of the deficient papilla is therefore, important. Perusal of available literature reveals only case reports and case series in the reconstruction of interdental papilla using subepithelial connective tissue graft and platelet rich fibrin autologous graft. Therefore, the current randomized controlled clinical study is intended to compare the effect of platelet rich fibrin and subepithelial connective tissue graft on interdental papilla reconstruction.
Read the detailed description
INTRODUCTION The rising concern for aesthetics has led to a change in the way dentistry is practised. Modern dentistry, no longer is aimed at only restoration of form and function, but restoration of aesthetics as well. Loss of interdental papilla gives rise to numerous problems such as retention of food, phonetic problems and an unaesthetic look. Reconstruction of this lost interdental papilla is one of the most challenging task as the lack of blood supply is a major obstacle in achieving the desired outcome of any attempts at regeneration.
Subepithelial connective tissue graft has been used for root coverage predictably. Studies in the form of case reports and case series have been done utilizing the connective tissue graft harvested from tuberosity, palate etc with encouraging results in the form of complete or partial interdental papilla fill.
Studies have been done to evaluate the usefulness of platelet rich fibrin(PRF) in regeneration of the interdental papilla. Use of PRF for augmentation of interdental papilla prevents the need for a second surgical site and thereby, the related complications associated with creation of a second surgical site.
On comprehensive search of literature, no study has been evident comparing the effect of subepithelial connective tissue graft and PRF for papilla augmentation. Therefore, the purpose of this study is to compare platelet rich fibrin and subepithelial connective tissue graft in interproximal papilla regeneration. The null hypothesis is that there is no significant difference in the clinical outcome for interdental papilla regeneration by platelet rich fibrin and subepithelial connective tissue graft.
Comparative evaluation of the clinical parameters in interdental papilla reconstruction by using platelet rich fibrin (Test group) and subepithelial connective tissue graft (Control group) MATERIALS AND METHODS The present prospective, analytical, randomized clinical trial will be conducted in the Department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences, Rohtak This interventional study includes 36 systemically healthy patients, with class I and class II papillary recession according to Nordland and Tarnow's classification. These will be divided into two groups equally (n = 18) Test group -Papilla reconstruction would be done with platelet rich fibrin Control group -Papilla reconstruction would be done with subepithelial connective tissue graft Patients will be recruited from the outpatient department of Post Graduate Institute of Dental Sciences, Rohtak Single blinding will be adopted where the investigator analysing the results will be unaware to which group the patient belongs.
All the participants will undergo full mouth supragingival and subgingival scaling and root planing with a combination of hand scalers and curettes (Hu Friedy) and ultrasonic scaler (EMS Piezon,250, Switzerland). Oral hygiene instructions will be imparted and will be reinforced at each appointment.
Local anaesthesia in the form of xylocaine HCl (2%) will be administered. 2mm coronal to the mucogingival junction of the involved papilla, a 3-5 mm semilunar incision will be given with an ophthalmic tunnel blade. Crevicular incisions will be given on the necks of the neighbouring teeth on the surfaces adjacent to the papilla defects. Through the semilunar incision given above, free the flap along with papilla from the underlying bone. The tissues will be completely freed from the bone and root, so that coronal displacement of the flap will be possible.
TEST GROUP Platelet rich fibrin (PRF) will be prepared according to the Choukron's protocol.
Trimming of the PRF according to the required size will be done. .PRF will be placed on the recipient site and suturing will be done with a 5-0 vicryl suture.
Periodontal dressing will be given over the surgical area. CONTROL GROUP Subepithelial connective tissue graft will be harvested from the maxillary premolars/first molar region. The graft will be then placed at the recipient site and suturing will be done with 5-0 vicryl suture. Periodontal dressing will be given over the surgical area.
In both the groups post operative instructions will be imparted. Antibiotics and analgesics will be prescribed for 5 days. All patients will be asked to rinse with 0.2% chlorhexidine gluconate twice a day for 2 weeks.
DATA COLLECTION METHODS PPD will be measured using UNC 15 periodontal probe at six sites (mesiobuccal, distobuccal, mesiolingual , distolingual , and median points at buccal and lingual aspect).
GI, PI will be measured using UNC 15 periodontal probe at four sites (distolabial, mesiolabial, labial, lingual gingival margin) Papillary height will be measured from apical aspect of contact point to tip of papilla with UNC 15 probe.
Width of Keratinized Gingiva will be measured with the help of UNC 15 probe from the mucogingival junction to the free gingival margin.
Clinical parameters will be recorded at different time intervals. Healing Index will be measured at 1 week, 2 weeks and 3 weeks. All the other clinical parameters will be measured at baseline, 3 months and 6 months and 1 year. The patients will be reinforced with oral hygiene instructions at every visit.
SAMPLE SIZE CALCULATION Based on data from the previously published study, a difference of 1mm between both test groups (standard deviation: 1.0 mm; significance level alpha: 0.05, power: 0.8) resulted in a sample size of 16 patients . To compensate for possible dropout, 18 patients per group will be recruited.
- Conditions
- Reconstructive Surgery
- Being tested
- interdental papilla reconstructive surgery with PRF, interdental papilla reconstructive surgery with subepithelial connective tissue graft
- Keywords
- interdental papilla reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdental papilla reconstructive surgery with PRFProcedure or surgery
Papilla reconstruction would be done with platelet rich fibrin
interdental papilla reconstructive surgery with subepithelial connective tissue graftProcedure or surgery
Papilla reconstruction would be done with subepithelial connective tissue graft
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Papilla reconstruction would be done with platelet rich fibrin Receives: Procedure: interdental papilla reconstructive surgery with subepithelial connective tissue graft |
| Control group | Active comparator | Papilla reconstruction would be done with subepithelial connective tissue graft Receives: Procedure: interdental papilla reconstructive surgery with PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in papillary height
Papillary height will be measured from apical aspect of contact point to tip of papilla with UNC 15 probe.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Dec 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nishi Tanwar, MDS, Study chair, PGIDS,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899051
- Sponsor's protocol ID
- perio isha
- Status last verified
- Mar 2019
- First submitted
- 30 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of Platelet Rich Fibrin and Subepithelial Connective Tissue Graft in Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03899051
- Acronym / sponsor ID
- perio isha
- Conditions
- Reconstructive Surgery
- Keywords
- interdental papilla reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 2 Apr 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.
Interdental papilla deficiency leads to food impaction, problems with phonetics and an unaesthetic appearance. Reconstruction of the deficient papilla is therefore, important. Perusal of available literature reveals only case reports and case series in the reconstruction of interdental papilla using subepithelial connective tissue graft and platelet rich fibrin autologous graft. Therefore, the current randomized controlled clinical study is intended to compare the effect of platelet rich fibrin and subepithelial connective tissue graft on interdental papilla reconstruction.
Detailed description
INTRODUCTION The rising concern for aesthetics has led to a change in the way dentistry is practised. Modern dentistry, no longer is aimed at only restoration of form and function, but restoration of aesthetics as well. Loss of interdental papilla gives rise to numerous problems such as retention of food, phonetic problems and an unaesthetic look. Reconstruction of this lost interdental papilla is one of the most challenging task as the lack of blood supply is a major obstacle in achieving the desired outcome of any attempts at regeneration.
Subepithelial connective tissue graft has been used for root coverage predictably. Studies in the form of case reports and case series have been done utilizing the connective tissue graft harvested from tuberosity, palate etc with encouraging results in the form of complete or partial interdental papilla fill.
Studies have been done to evaluate the usefulness of platelet rich fibrin(PRF) in regeneration of the interdental papilla. Use of PRF for augmentation of interdental papilla prevents the need for a second surgical site and thereby, the related complications associated with creation of a second surgical site.
On comprehensive search of literature, no study has been evident comparing the effect of subepithelial connective tissue graft and PRF for papilla augmentation. Therefore, the purpose of this study is to compare platelet rich fibrin and subepithelial connective tissue graft in interproximal papilla regeneration. The null hypothesis is that there is no significant difference in the clinical outcome for interdental papilla regeneration by platelet rich fibrin and subepithelial connective tissue graft.
Comparative evaluation of the clinical parameters in interdental papilla reconstruction by using platelet rich fibrin (Test group) and subepithelial connective tissue graft (Control group) MATERIALS AND METHODS The present prospective, analytical, randomized clinical trial will be conducted in the Department of Periodontics and Oral Implantology, Post Graduate Institute of Dental Sciences, Rohtak This interventional study includes 36 systemically healthy patients, with class I and class II papillary recession according to Nordland and Tarnow's classification. These will be divided into two groups equally (n = 18) Test group -Papilla reconstruction would be done with platelet rich fibrin Control group -Papilla reconstruction would be done with subepithelial connective tissue graft Patients will be recruited from the outpatient department of Post Graduate Institute of Dental Sciences, Rohtak Single blinding will be adopted where the investigator analysing the results will be unaware to which group the patient belongs.
All the participants will undergo full mouth supragingival and subgingival scaling and root planing with a combination of hand scalers and curettes (Hu Friedy) and ultrasonic scaler (EMS Piezon,250, Switzerland). Oral hygiene instructions will be imparted and will be reinforced at each appointment.
Local anaesthesia in the form of xylocaine HCl (2%) will be administered. 2mm coronal to the mucogingival junction of the involved papilla, a 3-5 mm semilunar incision will be given with an ophthalmic tunnel blade. Crevicular incisions will be given on the necks of the neighbouring teeth on the surfaces adjacent to the papilla defects. Through the semilunar incision given above, free the flap along with papilla from the underlying bone. The tissues will be completely freed from the bone and root, so that coronal displacement of the flap will be possible.
TEST GROUP Platelet rich fibrin (PRF) will be prepared according to the Choukron's protocol.
Trimming of the PRF according to the required size will be done. .PRF will be placed on the recipient site and suturing will be done with a 5-0 vicryl suture.
Periodontal dressing will be given over the surgical area. CONTROL GROUP Subepithelial connective tissue graft will be harvested from the maxillary premolars/first molar region. The graft will be then placed at the recipient site and suturing will be done with 5-0 vicryl suture. Periodontal dressing will be given over the surgical area.
In both the groups post operative instructions will be imparted. Antibiotics and analgesics will be prescribed for 5 days. All patients will be asked to rinse with 0.2% chlorhexidine gluconate twice a day for 2 weeks.
DATA COLLECTION METHODS PPD will be measured using UNC 15 periodontal probe at six sites (mesiobuccal, distobuccal, mesiolingual , distolingual , and median points at buccal and lingual aspect).
GI, PI will be measured using UNC 15 periodontal probe at four sites (distolabial, mesiolabial, labial, lingual gingival margin) Papillary height will be measured from apical aspect of contact point to tip of papilla with UNC 15 probe.
Width of Keratinized Gingiva will be measured with the help of UNC 15 probe from the mucogingival junction to the free gingival margin.
Clinical parameters will be recorded at different time intervals. Healing Index will be measured at 1 week, 2 weeks and 3 weeks. All the other clinical parameters will be measured at baseline, 3 months and 6 months and 1 year. The patients will be reinforced with oral hygiene instructions at every visit.
SAMPLE SIZE CALCULATION Based on data from the previously published study, a difference of 1mm between both test groups (standard deviation: 1.0 mm; significance level alpha: 0.05, power: 0.8) resulted in a sample size of 16 patients . To compensate for possible dropout, 18 patients per group will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: interdental papilla reconstructive surgery with subepithelial connective tissue graftPapilla reconstruction would be done with platelet rich fibrin |
| Control group | Active comparator | Procedure: interdental papilla reconstructive surgery with PRFPapilla reconstruction would be done with subepithelial connective tissue graft |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients in the age range of 18-55 years who are systemically healthy.
- Patients with class I and class II papillary recession according to Nordland and Tarnow's classification.
- Patients who have completed etiological periodontal therapy (full mouth scaling and root planing) with Plaque index (Silness \& Loe) <1, gingival index (Loe \& Silness) <1 and showing adequate compliance and willing to participate in the study.
Key exclusion criteria (6 listed)
- Patients having systemic diseases such as hypertension, diabetes, hyperthyroidism or on medications that influence the outcome of periodontal therapy.
- Presence of open contacts in the maxillary anterior region
- Presence of crowding in the maxillary anterior region.
- Pregnant and lactating women
- Patients with active periodontal disease
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 |
|---|---|---|
| interdental papilla reconstructive surgery with PRFPapilla reconstruction would be done with platelet rich fibrin | Procedure or surgery | Control group |
| interdental papilla reconstructive surgery with subepithelial connective tissue graftPapilla reconstruction would be done with subepithelial connective tissue graft | Procedure or surgery | Test group |
Primary outcome
Gain in papillary height
Time frame: 6 months
Papillary height will be measured from apical aspect of contact point to tip of papilla with UNC 15 probe.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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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.
Nishi Tanwar, MDS study chair
PGIDS,ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interdental papilla reconstructive surgery with PRF and interdental papilla reconstructive surgery with subepithelial connective tissue graft in people with Reconstructive Surgery, run by Postgraduate Institute of Dental Sciences Rohtak 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 6 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 2 Apr 2019. 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 Nishi Tanwar, MDS (8368126310, nsh_tanwar@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain in papillary height (time frame: 6 months). 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 2 Apr 2019.