Evaluation of a New Technique for Periodontal Pocket Reduction in the Extraction of Wisdom Teeth

NCT05722509 | Completed

• 1 other identifier: DRF1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

On many occasions, clinicians find situations in which they have to perform extractions of erupted or semi-erupted third molars or wisdom teeth where there are pre-existing periodontal pockets distal to the second molars, caused by a bone defect due to periodontal disease or due to malposition of the wisdom tooth concerning the second molar. After the extraction of an erupted or semi-included third molar, and as a consequence of factors related to dental malposition or bone defects caused by periodontal disease, periodontal pockets can arise on the distal surface of the second molar. When such exodontia is performed conventionally without raising a flap or applying any suturing technique in which there is a primary closure of the wound, there is a greater probability of persistence of periodontal pockets; and, in the worst case, they may increase after healing and closure of the alveolus. The consequence would be the formation of an enlarged and unattached tissue on the distal aspect of the second molar. The fact that periodontal pockets persist acts as an unfavorable prognostic factor. The predictive power of subsequent periodontal destruction increases since these are areas where bacteria will continue to accumulate (etiological factor of periodontal disease), and where the patient will not be able to access for their elimination and control. This is why a surgical technique called "distal wedge" has been proposed to eliminate these pockets. To avoid this second surgical procedure, we propose a procedure immediately after the conventional exodontic technique; where after performing a small gingivectomy and lifting a mucoperiosteal flap based on periodontal respective surgery concepts, primary closure of the alveolus and repositioning of the flaps at the level of the bone crest is achieved, eliminating these pre-existing pockets. This requires the existence of sufficient keratinized gingiva to maintain a band of at least 2 mm of keratinized tissue after the gingivectomy, thus ensuring a correct adherent tissue that provides sealing and proper maintenance of the periodontal tissues around the tooth. The proposed technique has been termed a "distal reduction flap" (DRF).

Conditions

Molar, Third; Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• Probing depth

  changes in probing depth

  6 and 18 weeks

Secondary Outcomes (1)

• Post-operative pain

  3 days

Study Arms (2)

"Distal Reduction Flap" Group

EXPERIMENTAL

A surgical procedure consisting of a tissue reduction flap distal to the second molar prior to the extraction of the third molar will be performed.

Procedure: "Distal Flap Reduction" Group

"Only Exodontia" Group

ACTIVE COMPARATOR

Exodontia of the 3rd molar will be performed following the different steps in the simple exodontic technique without performing any other surgical procedure.

Procedure: "Only Exodontia" Group

Interventions

"Only Exodontia" Group PROCEDURE

Third molar exodontia without associated surgery.

"Only Exodontia" Group

"Distal Flap Reduction" Group PROCEDURE

A surgical procedure consisting of a tissue reduction flap distal to the second molar prior to the extraction of the third molar will be performed.

"Distal Reduction Flap" Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require third molar extraction and who have periodontal pockets distal to the adjacent second molars.
• In the second molars there should be enough keratinized gingiva to allow for a buccal and/or lingual-palatal buckle (minimum residual band of 2 mm).
• Patients of either sex.
• Patients over 18 years old.
• Healthy patients or in a controlled periodontal situation (previously treated with basic periodontal therapy with scaling and root planing with probing depths of less than 4 mm and bleeding index at probing \<25%).
• In the case of pharmacologically treated patients, they should be properly controlled and request prior consultation to evaluate pharmacological treatments that may lead to hematological alterations.

You may not qualify if:

• Patients with uncontrolled pathologies or systemic conditions.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Clinica Universitaria Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (8)

• Robinson RE. The distal wedge operation. Periodontics. 1966 Sep-Oct;4(5):256-64. No abstract available.

  PMID: 5223126 BACKGROUND

• Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Bragger U, Zwahlen M, Lang NP. Influence of residual pockets on progression of periodontitis and tooth loss: results after 11 years of maintenance. J Clin Periodontol. 2008 Aug;35(8):685-95. doi: 10.1111/j.1600-051X.2008.01245.x. Epub 2008 Jul 23.

  PMID: 18549447 BACKGROUND

• Lindhe J, Socransky SS, Nyman S, Haffajee A, Westfelt E. "Critical probing depths" in periodontal therapy. J Clin Periodontol. 1982 Jul;9(4):323-36. doi: 10.1111/j.1600-051x.1982.tb02099.x.

  PMID: 6764782 BACKGROUND

• Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.

  PMID: 4507712 BACKGROUND

• Miyasato M, Crigger M, Egelberg J. Gingival condition in areas of minimal and appreciable width of keratinized gingiva. J Clin Periodontol. 1977 Aug;4(3):200-9. doi: 10.1111/j.1600-051x.1977.tb02273.x.

  PMID: 330574 BACKGROUND

• Stetler KJ, Bissada NF. Significance of the width of keratinized gingiva on the periodontal status of teeth with submarginal restorations. J Periodontol. 1987 Oct;58(10):696-700. doi: 10.1902/jop.1987.58.10.696.

  PMID: 2444693 BACKGROUND

• Claffey N, Nylund K, Kiger R, Garrett S, Egelberg J. Diagnostic predictability of scores of plaque, bleeding, suppuration and probing depth for probing attachment loss. 3 1/2 years of observation following initial periodontal therapy. J Clin Periodontol. 1990 Feb;17(2):108-14. doi: 10.1111/j.1600-051x.1990.tb01071.x.

  PMID: 2406292 BACKGROUND

• Heitz-Mayfield LJ, Lang NP. Surgical and nonsurgical periodontal therapy. Learned and unlearned concepts. Periodontol 2000. 2013 Jun;62(1):218-31. doi: 10.1111/prd.12008.

  PMID: 23574468 BACKGROUND

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Antonio Francisco López Sánchez, MD, PhD

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pre-measurements will be performed by 2 previously calibrated examiners (R.R.P and J.R.M). The calibration will consist of evaluating the periodontal probing of 10 patients in the mesial, distal, vestibular, and palatal/lingual areas and comparing the results of both examiners until an excellent degree of agreement is achieved. The surgical procedure will be performed by the principal investigator (RRM). Measurements of the results in the different study periods will be performed by a third independent evaluator (JFF) who will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 10, 2023
• Study Start: September 12, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 1, 2024
• Last Updated: May 5, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)