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Periodontal DiseasesNCT04356391

Pinhole Surgical Technique Compared to Connective Tissue Graft in Treatment of Gingival Recession

A study testing Connective Tissue Graft Technique and Pinhole Surgical Technique in people with Periodontal Diseases, run by State University of New York at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study compares the efficacy of root coverage achieved by the Pinhole Surgical Technique (PST) technique and the Connective Tissue Graft (CTG) technique in the treatment of Miller class I and II gingival recession defects. All patients will receive PST in one quadrant and CTG in another quadrant. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Periodontal Diseases
What is being tested?
Connective Tissue Graft Technique and Pinhole Surgical Technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
24 Jan 2018to 26 Apr 2023
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients should be above 18 years old.
  • The presence of Miller's class I or II gingival recession on at least two matching bilateral or contralateral gingival recession defects (≥ 2 mm).
  • Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
  • Absence of a history of periodontal surgery at the involved sites in the last 12 months.
  • History of compliance with oral hygiene instructions and periodontal recall.
  • Sufficient palatal or tuberosity donor tissue thickness (> 2mm).

Who cannot join

  • Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
  • Pregnant and lactating women
  • History of allergic reactions to drugs or materials used in the surgery including collagen.
  • Current use of any form of tobacco.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • 250 Squire Hall, Department of Periodontics, University at Buffalo

    Buffalo, New York, 14214

Other trials in United States

About this study

Official title: Efficacy of Pinhole Gum Rejuvenation Compared to Connective Tissue Graft in Treatment of Gingival Recession

This study compares the efficacy of root coverage achieved by the Pinhole Surgical Technique (PST) technique and the Connective Tissue Graft (CTG) technique in the treatment of Miller class I and II gingival recession defects. All patients will receive PST in one quadrant and CTG in another quadrant.

The hypothesis being tested is: Pinhole Surgical Technique outcomes are not inferior to those of the Connective Tissue Graft surgical technique.

Read the detailed description

Gingival recession is defined as the apical migration of the marginal gingiva and it leads to root surface exposure. It may be localized to a few sites or generalized to several teeth, and the severity may vary within the same person and between different people.

A variety of surgical techniques have been recommended to attain root coverage, including connective tissue graft, free gingival graft (FGG), pedicle flaps, double papilla grafts, coronally positioned flaps, coronal positioning of previously placed FGG, guided tissue regeneration (GTR), and the use of acellular dermal matrix (ADM), or enamel matrix derivatives. A recently developed technique used to attain root coverage is the Pinhole Surgical Technique (PST) described by Chao. This novel approach involves the separation of the gingiva and periosteum from the underlying bone with instruments inserted through a pinhole created in the vestibular area of the involved tooth while filling underneath the undermined interproximal papilla with strips of a bioresorbable membrane, rather than transferring gingival tissue from the palate to the area of recession. The advantage of this technique is the preservation of the gingival tissues and its blood supply, while freeing the flap from its apical attachment for ease of coronal displacement and adequate root coverage. In addition, the lack of a secondary surgical site may eliminate the accompanying pain and discomfort often reported in root coverage procedures.

The connective tissue graft technique was described by Langer and Langer in 1985, in which the patient's own connective tissue is taken mostly from the palate and used to cover the area of recession. The retro-molar pad area (tuberosity) has also been used because of the thickening of the sub-mucosa in that area. This graft material is carefully sutured into place and a coronally advanced flap placed and sutured over it, while part of the graft can be left exposed. Currently the connective tissue graft (CTG) is the most common and predictable treatment for gingival recession, and is considered the gold standard. Key advantages of the connective tissue graft procedure are the availability of two sources of blood supply to the graft: one from the recipient bed, and the other from the overlying flap, the perfect chromatic integration, an optimal esthetic outcome, and excellent color match. In addition, an increase in the thickness of the gingival tissues and the width of keratinized gingiva has been documented with the ability for creeping attachment which is not possible with the use of bioresorbable collagen membranes.

Being tested
Connective Tissue Graft Technique, Pinhole Surgical Technique
Keywords
Gingival Recession, Marginal Gingiva, Root Coverage
Medical subject headings
Periodontal Diseases, Gingival Recession

What participants receive

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

  • Connective Tissue Graft TechniqueProcedure or surgery

    Also called Graft Harvested from the Palate

    For the sites receiving the control technique (Connective Tissue Graft), the technique described by Langer B. and Langer L. will be started with a sulcular incision followed by a partial thickness flap. A CTG is then harvested according to the technique described by Bruno, the first incision is perpendicular to the 2nd premolar and 1st molar and is 2-3mm apical to their gingival margin as wide as the recipient site, followed by a second incision parallel to the for mentioned teeth, 1-2mm apical to the first incision, then the CTG is raised by periosteal elevator and released from apical and lateral attachments by sharp incision when needed. The graft is then prepared to have a homogenous thickness of 1.5-2mm. The donor CTG is stabilized to the underlying connective tissue interproximally using 4-0 Vicryl sutures. The recipient flap is repositioned coronally, to cover as much as possible of the graft with no tension, 2mm coronal to the CEJ, then sutured with 4-0 Vicryl sutures.

  • Pinhole Surgical TechniqueProcedure or surgery

    Also called Collagen Resorbable Membrane Material

    For the sites receiving the test technique (Chao Pinhole Surgical Technique) the surgery starts with a small pinhole opening in the alveolar mucosa apical to the mucogingival junction of the affected tooth, the flap is then undermined using special instruments to create a full thickness pouch, followed by extending the pouch horizontally and coronally to undermined the adjacent papilla without incising it and free the flap for its coronal displacement. Then multiple 2x12mm strips of collagen resorbable membrane material (Bio-Gide, Geistlich Pharma AG) are packed under the papilla to secure the flap in a coronal direction. Gentle pressure is applied for 5 minutes to minimize the thickness of the blood clot after each of the procedures. The patients are advised to brush all teeth and sites except the buccal surfaces of the operated-on teeth, which are to be cleaned with 0.12% Chlorhexidine mouth rinse.

Study groups in NCT04356391
Study groupRoleWhat they receive
Connective Tissue Graft harvest from PalateActive comparatorIn each participant, a tooth will be assigned to the Connective Tissue Graft (CTG) technique and another tooth to the Pinhole Technique. The tooth assigned to the CTG technique will receive the graft harvested from the palate.
Receives: Procedure: Connective Tissue Graft Technique
collagen resorbable membrane materialExperimentalIn each participant, a tooth will be assigned to the Connective Tissue Graft (CTG) technique and another tooth to the Pinhole Surgical Technique (PST). The tooth assigned to the PST technique will receive the collagen resorbable membrane material.
Receives: Procedure: Pinhole Surgical Technique

What is being measured

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

  1. Change in (Complete root coverage determined by recession classification, percentage root coverage, and recession depth, Pain Index, Healing Index) is being assessed.

    Complete root coverage (CRC): The number of sites that resulted in 100% root coverage.

    Measured: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months

  2. Change in percentage root coverage is being assessed

    Percentage root coverage (%RC): calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.

    Measured: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months

  3. recession depth

    Recession Depth (RD): Measured in millimeters from the gingival margin at the mid-buccal aspect of the root, to the Cemento-Enamel Junction (CEJ) or relative CEJ.

    Measured: 2 weeks preoperative

  4. Change in Pain Index is being assessed

    Pain index (PN): Pain is recorded on a horizontal pain scale of 0-10. Pain index as follows; Mild for ''0 to 3,'' moderate for ''4 to 6,'' and severe for ''7 to 10.''

    Measured: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months

  5. Change in Healing Index is being assessed

    Healing index (HI): A horizontal scale from 1-5 evaluating tissue color, response to palpation, granulation tissue, incision margin, suppuration, adopted from Aleksic. 1 (very poor). 2 (poor). 3 (good). 4 (very good).

    Measured: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months

Secondary outcomes (5)

  1. Change in periodontal parameters (clinical attachment level) is being assessed

    Clinical attachment level (CAL): Measured in millimeters from CEJ or relative CEJ to the base of the periodontal sulcus at 6 sites per tooth.

    Measured: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

  2. change in periodontal parameters (probing depth) is being assessed

    Probing depth (PD): Measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth.

    Measured: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

  3. change in periodontal parameters (width of keratinized tissue) is being assessed.

    Width of the keratinized tissue (KTW): Measured in millimeters at mid-buccal aspect of the tooth from the gingival margin to the mucogingival junction.

    Measured: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

  4. Change in periodontal parameters (gingival thickness) is being assessed.

    Gingival Thickness: Measured in millimeters at the mid-buccal of the gingiva and 2 mm apical the gingival margin at the attached gingiva or the alveolar mucosa using a #15 endodontic reamer with a silicon disk stop.

    Measured: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

  5. Change in periodontal parameters (gingival index) is being assessed.

    Gingival index (GI): GI is measured according to Loe and Sillness and scored on a scale of 0 to 3.

    Measured: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

Timeline

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

  1. First posted22 Apr 2020
  2. Study start24 Jan 2018
  3. Primary completion2 Aug 2022
  4. Study completion26 Apr 2023

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
Randomized, split-mouth, double blinded design clinical trial.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356391
Sponsor's protocol ID
STUDY00001141
Status last verified
May 2023
First submitted
29 Jan 2020
Last updated
25 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: If decided to share data, through publication in one of the journals, then it would include but not limited to statistical analysis, abstract, manuscript, consent forms, tables used for evaluations, and results.

Publications

  • Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.

    PubMed 3858267

  • Albandar JM, Kingman A. Gingival recession, gingival bleeding, and dental calculus in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):30-43. doi: 10.1902/jop.1999.70.1.30.

    PubMed 10052768

  • Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco R; Research, Science and Therapy Committee. Oral reconstructive and corrective considerations in periodontal therapy. J Periodontol. 2005 Sep;76(9):1588-600. doi: 10.1902/jop.2005.76.9.1588.

    PubMed 16171452

  • Langer L, Langer B. The subepithelial connective tissue graft for treatment of gingival recession. Dent Clin North Am. 1993 Apr;37(2):243-64.

    PubMed 8477867

  • Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.

    PubMed 3866056

  • Miller PD Jr. Root coverage using a free soft tissue autograft following citric acid application. Part 1: Technique. Int J Periodontics Restorative Dent. 1982;2(1):65-70. No abstract available.

    PubMed 6959974

  • Holbrook T, Ochsenbein C. Complete coverage of the denuded root surface with a one-stage gingival graft. Int J Periodontics Restorative Dent. 1983;3(3):8-27. No abstract available.

    PubMed 6358084

  • Grupe HE, Warren RF. Repair of Gingival Defects by a Sliding Flap Operation. Journal of periodontology 1956;27:92-95.

  • Pfeifer JS, Heller R. Histologic evaluation of full and partial thickness lateral repositioned flaps: a pilot study. J Periodontol. 1971 Jun;42(6):331-3. doi: 10.1902/jop.1971.42.6.331. No abstract available.

    PubMed 5282573

  • Cohen DW, Ross SE. The double papillae repositioned flap in periodontal therapy. J Periodontol. 1968 Mar;39(2):65-70. doi: 10.1902/jop.1968.39.2.65. No abstract available.

    PubMed 4870433

  • Ross SE, Crosetti HW, Gargiulo A, Cohen DW. The double papillae repositioned flap--an alternative. I. Fourteen years in retrospect. Int J Periodontics Restorative Dent. 1986;6(6):46-59. No abstract available.

    PubMed 3468092

  • Bernimoulin JP, Luscher B, Muhlemann HR. Coronally repositioned periodontal flap. Clinical evaluation after one year. J Clin Periodontol. 1975 Feb;2(1):1-13. doi: 10.1111/j.1600-051x.1975.tb01721.x.

    PubMed 1055724

  • Allen EP, Miller PD Jr. Coronal positioning of existing gingiva: short term results in the treatment of shallow marginal tissue recession. J Periodontol. 1989 Jun;60(6):316-9. doi: 10.1902/jop.1989.60.6.316.

    PubMed 2778599

  • Sorrentino JM, Tarnow DP. The semilunar coronally repositioned flap combined with a frenectomy to obtain root coverage over the maxillary central incisors. J Periodontol. 2009 Jun;80(6):1013-7. doi: 10.1902/jop.2009.080553.

    PubMed 19485834

  • Tarnow DP. Semilunar coronally repositioned flap. J Clin Periodontol. 1986 Mar;13(3):182-5. doi: 10.1111/j.1600-051x.1986.tb01456.x.

    PubMed 3457805

Questions about this trial

What is this clinical trial studying?

A study testing Connective Tissue Graft Technique and Pinhole Surgical Technique in people with Periodontal Diseases, run by State University of New York at Buffalo at 1 site in United States.

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 4 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 25 May 2023. 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 United States. 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?

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?

Change in (Complete root coverage determined by recession classification, percentage root coverage, and recession depth, Pain Index, Healing Index) is being assessed. (time frame: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months). The study lists 5 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 NCT04356391, which also lists 22 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 25 May 2023.

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