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Completed

NCT Number: NCT04345744

Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing

Evaluate the response of the gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the periodontal surgical wound.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Pisa

Pisa, 56121, Italy

About this study

Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD) and presence of recession of the gingival margin (Rec) will be recorded on six sites/tooth in the area selected for periodontal surgery by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe at a 0.3 N probing pressure. Surgery will be performed following a standardized protocol by a single operator.

After surgery, patients will be randomly assigned to study groups corresponding to mouth rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the following steps of the study, in order to maintain the examiner blind. The patient will receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The patient will also be given a diary for the registration of the number of rinses per day, to be returned to the examiner at T14. The mouth rinse protocol assigned to each study participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

The patients will be allocated in one of the three distinct study groups as it follows:

  • Group A: no administration of mouth rinses after surgery (control group)
  • Group B: administration of a hyaluronic and 0.2% chlorhexidine mouth rinse (test group 1)
  • Group C: administration of chlorhexidine 0.2% mouth rinse (test group 2).

Post-treatment photographs of surgical incision will be taken immediately after periodontal surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of the degree of wound healing. The degree of surgical healing will be evaluated using the Periodontal Wound Healing Index (Wachtel classification) on all the incisions, and a score from 1 to 5 will be assigned.

At T3, T7, and T14 the following clinical parameters will be recorded for each tooth in the surgical area: PPD, Rec, PI, and BOP. The clinical examinations will be performed by calibrated examiner blind to group allocation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males or females of age range between 18 and 70 years,
  • good health status,
  • indication to perform periodontal surgery,
  • patients willing to give informed consent,
  • compliance to the study follow-up,
  • plaque index (PI) score 0 and
  • bleeding on probing (BOP) <25%

Exclusion criteria

  • pregnancy or breast-feeding,
  • therapy with oral contraceptives,
  • indication to antibiotic therapy prior to surgical treatment,
  • chronic infections,
  • systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
  • previous therapy with the mouth rinses employed in the present study, and
  • smoking habit (>20 cigarettes per day, and/or pipe or cigar smoking).

Treatment and study plan

Periodontal surgery

Procedure

Surgery will be performed following a standardized protocol by a single operator (FG). The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision.

Hyaluronic and 0.2% chlorhexidine mouth rinse

Device

The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

Chlorhexidine 0.2% mouth rinse

Device

The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

Primary outcomes

  1. Pocket probing depth (PPD)

    Time frame: Measured at Baseline and at day 3, day 7, and day 14

    Changes in PPD, measured orally through clinical examination. Unit of measure: mm

Secondary outcomes

  1. Clinical attachment level (CAL)

    Time frame: Measured at Baseline and at day 3, day 7, and day 14

    Changes in CAL , measured orally through clinical examination. Unit of measure: mm

  2. Recession of the gingival margin (REC)

    Time frame: Measured at Baseline and at day 3, day 7, and day 14

    Changes in REC, measured orally through clinical examination. Unit of measure: mm

  3. Bleeding on probing (BOP)

    Time frame: Measured at Baseline

    BOP, measured orally through clinical examination. Unit of measure: %

  4. Angulated bleeding index (AngBI)

    Time frame: Measured at day 3, day 7, and day 14

    AngBI, measured orally through clinical examination. Unit of measure: %

  5. Plaque index (PI)

    Time frame: Measured at Baseline and at day 3, day 7, and day 14

    Changes in PI, measured orally through clinical examination. Unit of measure: %

  6. Periodontal Wound Healing Index (PWHI) (Wachtel classification)

    Time frame: Measured at day 3, day 7, and day 14

    Changes in PWHI, measured orally through clinical examination on all the incisions, assigning a score from 1 to 5.

    • Score 1: complete wound healing: absence of fibrin line in the interproximal area
    • Score 2: complete wound healing: presence of a thin fibrin line in the interproximal area
    • Score 3: complete wound healing: presence of fibrin clot in the interproximal area
    • Score 4: incomplete wound healing: presence of partial necrosis of the interproximal area
    • Score 5: incomplete wound healing: total necrosis of the interproximal area
  7. Post-surgical photographs

    Time frame: Taken at Baseline, day 3, day 7, and day 14

    Post-surgical photographs will be taken and analysed after the completion of the trial

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Acronym: CLOR_3

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Apr 14, 2020
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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