Gingival Recession, GeneralizedPRPNCT03043638
Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions
A study testing CAF+ADM+PRP and CAF+ADM in people with Gingival Recession, Generalized, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
Trial summary
The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP) combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in the treatment of multiple adjacent gingival recessions (MAGRs). 12 patients with 84 Miller Class I or II recession defects were participated. Read more about this study
- Who is it for?
- Ages 34 to 57 years
- Conditions the study is for
- Gingival Recession, Generalized
- What is being tested?
- CAF+ADM+PRP and CAF+ADM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2008to 20 Jun 2011
- 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 34 to 57 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of the presence of at least three multiple adjacent Miller class I or II recessions on both sides of the same maxillary or mandibular arch
- must be able to have 2 mm-high keratinized tissue apical to the root exposures;
- must be able to have no systemic diseases that could influence the outcome of the therapy;
- must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);
- must be non-smoker;
- must be not pregnant.
Who cannot join
- debilitating systemic or infectious diseases (human immunodeficiency virus or hepatitis) -- -any disease that significantly affects the periodontium;
- known allergy to any of the materials used in the study; requirement for antibiotic prophylaxis;
- taking medications known to interfere with periodontal health and healing not detectable cemento-enamel junction (CEJ);
- restorations or caries at the recession site;
- failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or lactation; use of tobacco products; alcohol abuse;
- a previous periodontal surgery at the recession site and failure to complete the informed consent.
About this study
Official title: Efficiency of Platelet-Rich Plasma (PRP) on Acellular Dermal Matrix Application With Coronally Advanced Flap in the Treatment of Multiple Adjacent Gingival Recessions:a Double-masked Randomized Controlled Clinical Trial
The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP) combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in the treatment of multiple adjacent gingival recessions (MAGRs).
12 patients with 84 Miller Class I or II recession defects were participated. Sites were randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD), recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively. The data were analyzed statistically.
Read the detailed description
Several methods have been demonstrated for the treatment of gingival recession defects with the use of PRP. In an 8-month randomized controlled trial, it was reported that there was no significant difference between PRP and CTG treated groups in terms of root coverage of Miller Class 1 or II buccal recession defects. However, in the same study contour and texture of soft tissue showed valuable enhancement in PRP group. The use of PRP together with ADM in the treatment of MAGRs may alleviate the need for autogenous donor tissue. Shepherd et al. compared coronally positioned tunnel technique and ADM application with and without PRP for the treatment of single gingival recession defects and reported no statistically significant root coverage difference between groups.
Although there are numerous root coverage procedures to treat the conditions, predictable coverage of multiple adjacent gingival recessions still remains a challenge for the clinician. The aim of this randomized, controlled, clinical trial was to compare the CAF plus ADM application together with and without PRP to determine whether the PRP provided an advantage in terms of gaining coverage of deep and wide recession defects in the treatment of MAGRs.
In the present study, using a controlled blinded split-mouth design, 14 patients with multiple Miller Class I or II adjacent recession defects ≥ 3mm deep on bilateral operation sites were randomly operated either with CAF+ADM+PRP or only CAF+ADM as test and control groups respectively. Two patients who failed to return for all postoperative visits were exited from the study.
Finally12 patients who had adjacent Miller Class 1 or II (Miller) recession defects ≥ 3mm deep on non-molar teeth in the same dental arch at least two bilateral site, underwent through root coverage surgery and were followed for 12 months. The study sample consisted of 84 teeth associated with total of 12 patients; seven patients each showing a pair of three teeth, four patients each showing a pair of four teeth, and one patient showing a pair of five teeth with adjacent multiple recessions deep on the buccal aspect of each tooth. The treated teeth were 26 incisors, 24 canines and 34 first premolars. Standardized radiographs were taken to evaluate the interproximal alveolar bone level. At baseline, 3, 6 and 12 months after the surgeries; Miller classification of the recession defect (Miller, 1985), plaque index (PI) (Silness and Loe, 1964), gingival index (GI) (Loe, 1967) probing depth (PD), clinical attachment level(CAL), Probing depth(PD), gingival margin (GM), Gingival recession width (GRW) were recorded. The pre-surgical evaluation included an analysis of the patient's tooth brushing technique and habits. At the teeth showing gingival recessions, a coronally directed roll technique using a soft toothbrush was indicated to minimize the tooth brushing trauma to the gingival margin. Pre-surgical therapy included scaling, root planning, polishing and general oral hygiene instruction. All surgical procedures were performed with Coronally Advanced Flap technique.
- Conditions
- Gingival Recession, Generalized
- Being tested
- CAF+ADM+PRP, CAF+ADM
- Keywords
- multiple adjacent gingival recessions, platelet rich plasma, acellular dermal matrix, coronally advanced flap, gingival recession, root coverage, clinical attachment level
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF+ADM+PRPProcedure or surgery
CAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing.
CAF+ADMProcedure or surgery
CAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application
| Study group | Role | What they receive |
|---|---|---|
| CAF+ADM+PRP | Experimental | Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP) Receives: Procedure: CAF+ADM+PRP |
| CAF+ADM | Active comparator | Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP Receives: Procedure: CAF+ADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root coverage (RC)
The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.
Measured: The change in RC at 3rd month to 12th month
Secondary outcomes (6)
Gingival recession depth (GRD)
The GRD was measured from the CEJ to the GM. PD, CAL and GRD were measured at the same reference points.
Measured: Baseline, 3,6 and 12 months after periodontal surgery
recession width (GRW)
Gingival recession width (GRW) was measured with perpendicular positioning of the periodontal probe to the cemento-enamel junction, the distance between the top of the papilla at the mesial and distal aspect of the tooth was recorded.
Measured: Baseline, 3,6 and 12 months after periodontal surgery
width of keratinized tissue (WKT)
Width of keratinized tissue (WKT) was measured at the mid-buccal point from the mucogingival junction (MGJ) to the free GM by a digital caliper.
Measured: Baseline, 3,6 and 12 months after periodontal surgery
plaque index(PI)
plaque index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
Measured: Baseline, 3,6 and 12 months after periodontal surgery
gingival index
gingival index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
Measured: Baseline, 3,6 and 12 months after periodontal surgery
probing depth
PD was measured at three points (mesio-buccal, midbuccal, and disto-buccal) on the individual elastomeric stent and calculated as the distance between gingival margin (GM) and the bottom of the sulcus.
Measured: Baseline, 3,6 and 12 months after periodontal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start1 Jul 2008
- Primary completion20 Jun 2011
- Study completion20 Jun 2011
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 Gingival Recession, GeneralizedStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, PELİN GÖKALP, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Pelin Gokalp, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043638
- Sponsor's protocol ID
- 03/2007-28
- Acronym
- PRP
- Status last verified
- Jan 2017
- First submitted
- 2 Feb 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When needed data can be shared via email.
Publications
Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.
PubMed 19254123Cetiner D, Gokalp Kalabay P, Ozdemir B, Cankaya ZT. Efficiency of platelet-rich plasma on acellular dermal matrix application with coronally advanced flap in the treatment of multiple adjacent gingival recessions: A randomized controlled clinical trial. J Dent Sci. 2018 Sep;13(3):198-206. doi: 10.1016/j.jds.2017.11.002. Epub 2018 Feb 3.
PubMed 30895121
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Platelet-Rich Plasma (PRP) on Acellular Dermal Matrix Application With Coronally Advanced Flap in the Treatment of Multiple Adjacent Gingival Recessions:a Double-masked Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03043638
- Acronym / sponsor ID
- PRP / 03/2007-28
- Conditions
- Gingival Recession, Generalized
- Keywords
- multiple adjacent gingival recessions, platelet rich plasma, acellular dermal matrix, coronally advanced flap, gingival recession, root coverage, clinical attachment level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- 20 Jun 2011 (actual)
- Study completion
- 20 Jun 2011 (actual)
- First posted
- 6 Feb 2017 (estimated)
- 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 aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP) combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in the treatment of multiple adjacent gingival recessions (MAGRs).
12 patients with 84 Miller Class I or II recession defects were participated. Sites were randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD), recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively. The data were analyzed statistically.
Detailed description
Several methods have been demonstrated for the treatment of gingival recession defects with the use of PRP. In an 8-month randomized controlled trial, it was reported that there was no significant difference between PRP and CTG treated groups in terms of root coverage of Miller Class 1 or II buccal recession defects. However, in the same study contour and texture of soft tissue showed valuable enhancement in PRP group. The use of PRP together with ADM in the treatment of MAGRs may alleviate the need for autogenous donor tissue. Shepherd et al. compared coronally positioned tunnel technique and ADM application with and without PRP for the treatment of single gingival recession defects and reported no statistically significant root coverage difference between groups.
Although there are numerous root coverage procedures to treat the conditions, predictable coverage of multiple adjacent gingival recessions still remains a challenge for the clinician. The aim of this randomized, controlled, clinical trial was to compare the CAF plus ADM application together with and without PRP to determine whether the PRP provided an advantage in terms of gaining coverage of deep and wide recession defects in the treatment of MAGRs.
In the present study, using a controlled blinded split-mouth design, 14 patients with multiple Miller Class I or II adjacent recession defects ≥ 3mm deep on bilateral operation sites were randomly operated either with CAF+ADM+PRP or only CAF+ADM as test and control groups respectively. Two patients who failed to return for all postoperative visits were exited from the study.
Finally12 patients who had adjacent Miller Class 1 or II (Miller) recession defects ≥ 3mm deep on non-molar teeth in the same dental arch at least two bilateral site, underwent through root coverage surgery and were followed for 12 months. The study sample consisted of 84 teeth associated with total of 12 patients; seven patients each showing a pair of three teeth, four patients each showing a pair of four teeth, and one patient showing a pair of five teeth with adjacent multiple recessions deep on the buccal aspect of each tooth. The treated teeth were 26 incisors, 24 canines and 34 first premolars. Standardized radiographs were taken to evaluate the interproximal alveolar bone level. At baseline, 3, 6 and 12 months after the surgeries; Miller classification of the recession defect (Miller, 1985), plaque index (PI) (Silness and Loe, 1964), gingival index (GI) (Loe, 1967) probing depth (PD), clinical attachment level(CAL), Probing depth(PD), gingival margin (GM), Gingival recession width (GRW) were recorded. The pre-surgical evaluation included an analysis of the patient's tooth brushing technique and habits. At the teeth showing gingival recessions, a coronally directed roll technique using a soft toothbrush was indicated to minimize the tooth brushing trauma to the gingival margin. Pre-surgical therapy included scaling, root planning, polishing and general oral hygiene instruction. All surgical procedures were performed with Coronally Advanced Flap technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+ADM+PRP | Experimental | Procedure: CAF+ADM+PRPSurgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP) |
| CAF+ADM | Active comparator | Procedure: CAF+ADMSurgery will include only Coronally advanced flap CAF technique including ADM placement without PRP |
Who may qualify
- Ages
- 34 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of the presence of at least three multiple adjacent Miller class I or II recessions on both sides of the same maxillary or mandibular arch
- must be able to have 2 mm-high keratinized tissue apical to the root exposures;
- must be able to have no systemic diseases that could influence the outcome of the therapy;
- must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);
- must be non-smoker;
Key exclusion criteria (6 listed)
- debilitating systemic or infectious diseases (human immunodeficiency virus or hepatitis) -- -any disease that significantly affects the periodontium;
- known allergy to any of the materials used in the study; requirement for antibiotic prophylaxis;
- taking medications known to interfere with periodontal health and healing not detectable cemento-enamel junction (CEJ);
- restorations or caries at the recession site;
- failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or lactation; use of tobacco products; alcohol abuse;
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 |
|---|---|---|
| CAF+ADM+PRPCAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing. | Procedure or surgery | CAF+ADM+PRP |
| CAF+ADMCAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application | Procedure or surgery | CAF+ADM |
Primary outcome
Root coverage (RC)
Time frame: The change in RC at 3rd month to 12th month
The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.
6 secondary outcomes
Gingival recession depth (GRD)
Time frame: Baseline, 3,6 and 12 months after periodontal surgery
recession width (GRW)
Time frame: Baseline, 3,6 and 12 months after periodontal surgery
width of keratinized tissue (WKT)
Time frame: Baseline, 3,6 and 12 months after periodontal surgery
plaque index(PI)
Time frame: Baseline, 3,6 and 12 months after periodontal surgery
gingival index
Time frame: Baseline, 3,6 and 12 months after periodontal surgery
probing depth
Time frame: Baseline, 3,6 and 12 months after periodontal surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 19254123Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.
- Derived from this study: PubMed 30895121Cetiner D, Gokalp Kalabay P, Ozdemir B, Cankaya ZT. Efficiency of platelet-rich plasma on acellular dermal matrix application with coronally advanced flap in the treatment of multiple adjacent gingival recessions: A randomized controlled clinical trial. J Dent Sci. 2018 Sep;13(3):198-206. doi: 10.1016/j.jds.2017.11.002. Epub 2018 Feb 3.
- Individual participant dataSharing planned: Yes. When needed data can be shared via email.
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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.
Pelin Gokalp principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing CAF+ADM+PRP and CAF+ADM in people with Gingival Recession, Generalized, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
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 6 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: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root coverage (RC) (time frame: The change in RC at 3rd month to 12th month). 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 NCT03043638, 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 8 Feb 2017.